IPCSUPER: Intermittent Pneumatic Compression in Surgical Patients at Extremely-high Risk for Venous Thromboembolism

• Sponsor: Pirogov Russian National Research Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03044574
• Collaborator: Medtronic (Industry)
• Enrollment: 407
• Locations: 2
• Arms: 2
• Actual Duration (Months): 22.9
• Patients Per Site: 203.5
• Patients Per Site Per Month: 8.9

Study Details

Study Description

Brief Summary

The aim of the study is to evaluate efficacy and safety of venous thromboembolism prophylaxis by the combination of graduated compression stockings (GCS), standard doses of low-molecular-weight heparins (LMWH) and sequential compression device (SCD) in the mixed group of surgical patients at high and extremely high risk for venous thromboembolism.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism; Venous Thrombosis	Device: SCD; Device: GCS; Drug: LMWH	N/A

Detailed Description

Venous thromboembolism (VTE) is the most common complication after major surgery, especially in high-risk patients. But the high-risk group is inhomogeneous. Some patients included in this group have an extremely high prevalence of postoperative venous thrombosis and pulmonary embolism, in whom the standard complex prophylaxis with elastic compression and standard anticoagulation is less effective. This is particularly so, in patients having a Caprini score of 11 and more, so that at the background of standard prophylaxis postoperative DVT is 10 times higher. This group of patients needs a more effective protocol for VTE prevention.

Sequential compression devices (SCD) combined with graduated elastic compression stockings (GCS) or without them were found to be effective in the prevention of VTE in high-risk patients, especially after neurosurgical interventions, even without the administration of anticoagulants. However, their efficacy in patients at "extremely high risk", having 11+ Caprini scores has not been assessed yet. The aim of the current study is to evaluate efficacy and safety of VTE prophylaxis by the combination of graduated compression stockings (GCS), standard doses of low-molecular-weight heparins (LMWH) and sequential compression device (SCD) in the mixed group of surgical patients at high and extremely high risk for venous thromboembolism

The expected outcome of the study is a reduction of asymptomatic postoperative venous thrombosis rate in the hospital and reduction in all VTE during 6 months after discharge.

Study Design

• Study Type: Interventional
• Actual Enrollment: 407 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A randomized clinical study to assess efficacy and safety of intermittent pneumatic compression device (SCD) application in combined prevention of postoperative VTE in surgical patients at high and extremely high risk receiving graduated compression stockings and early/delayed prophylactic anticoagulation with low-molecular weight heparins.A randomized clinical study to assess efficacy and safety of intermittent pneumatic compression device (SCD) application in combined prevention of postoperative VTE in surgical patients at high and extremely high risk receiving graduated compression stockings and early/delayed prophylactic anticoagulation with low-molecular weight heparins.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Trial to Assess the Effectiveness of Intermittent Pneumatic Compression in the Prevention of Postoperative Venous Thromboembolism in Surgical Patients at Extremely High Risk
• Actual Study Start Date: Feb 1, 2017
• Actual Primary Completion Date: Sep 30, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group (SCD + GCS + LMWH) SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge. GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.	Device: SCD; Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.; Device: GCS; Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge; Drug: LMWH; LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
Active Comparator: Control group (GCS + LMWH) GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.	Device: GCS; Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge; Drug: LMWH; LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Asymptomatic Venous Thrombosis of Lower Limbs as Detected by Duplex Ultrasound [time of discharge from the hospital or death, up to 45 days]

   Asymptomatic deep and/or superficial vein thrombosis of lower limbs detected by duplex ultrasound performed at baseline and then every 3-5 days after surgery until discharge.

Secondary Outcome Measures

1. Number of Patients With Proximal Deep Venous Thrombosis as Detected by Duplex Ultrasound [time of discharge from the hospital or death, up to 45 days]

   Proximal deep vein thrombosis defined as thrombus of popliteal, femoral, iliac veins and/or inferior vena cava. Detected by duplex ultrasound performed at baseline and then every 3-5 days after surgery until discharge.

2. Number of Patients With Isolated Calf Muscle Vein Thrombosis as Detected by Duplex Ultrasound [time of discharge from the hospital or death, up to 45 days]

   Isolated calf muscle vein thrombosis was defined as thrombosis of soleal, gastrocnemius or other calf muscle veins not extended into tibial, or peroneal, or popliteal veins. Detected by duplex ultrasound performed at baseline and then every 3-5 days after surgery until discharge.

3. Number of Patients With Pulmonary Embolism [time of discharge from the hospital or death, up to 45 days]

   Symptomatic pulmonary embolism (PE) that occurred during the inpatient period of treatment and confirmed by computed tomography pulmonary angiogram (CTPA) or single-photon emission computed tomography with computed tomography (SPECT/CT) or autopsy

4. Number of Patients Died From Any Reason [time of discharge from the hospital or death, up to 45 days]

   Inpatient postoperative mortality: number of patients died from any reason during the inpatient period of treatment

5. Number of Patients With Leg Skin Injury [time of discharge from the hospital or death, up to 45 days]

   Leg skin injury defined as any skin hyperemia, maceration, laceration, bubbles, erosion or ulceration in the zone of application for GCS and SCD on the lower limbs revealed by clinical inspection of the skin and soft tissues until discharge

6. Number of Patients With Symptomatic and Asymptomatic VTE Events at 30 Days After Surgery [30 days]

   Taking into account all VTE events: asymptomatic revealed by duplex ultrasound, symptomatic confirmed by duplex ultrasound, CTPA, SPECT/CT, autopsy in patients discharged from the hospital and still receiving inpatients care at 30 days after surgery.

7. Number of Patients Who Died From VTE at 30 Days After Surgery [30 days]

   VTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy

8. Number of Patients With Symptomatic and Asymptomatic VTE Events at 180 Days After Surgery [180 days]

   Taking into account all symptomatic and asymptomatic VTE events confirmed by duplex ultrasound, CTPA, SPECT/CT, autopsy or other appropriate methods of diagnosis that occurred during the inpatient period of treatment and outpatient period of observation

9. Number of Patients Who Died From VTE at 180 Days After Surgery [180 days]

   VTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy

Other Outcome Measures

1. Duration of Inpatient Period of Treatment [time of discharge from the hospital or death, up to 45 days]

   The inpatient period of treatment suggests time from surgical intervention to discharge from the hospital or death.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age over 40

• Major surgery undergone*

• High risk of postoperative VTE according to a National guideline**

• 11+ Caprini scores

• Informed consent is given

Exclusion Criteria:

• Acute deep vein thrombosis (DVT) at baseline

• Performed inferior vena cava (IVC) plication or implanted IVC filter

• Regular preoperative anticoagulation

• Postoperative anticoagulation needed at therapeutic doses

• Absence of anticoagulation for more than 5 days after surgery

• Coagulopathy (not related to Disseminated intravascular coagulation syndrome)

• Thrombocytopenia

• Hemorrhagic diathesis

• Lower limb soft tissue infection

• Ankle-brachial index < 0.6

• Major surgery - intervention under endotracheal anesthesia with duration of more than 60 min.

• In accordance with a standard stratification system, high risk of VTE group includes patients over 60 years old after major surgery and patients 40-60 years old with additional risk factors after major surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Hospital no.1 of the President's Administration of Russian Federation	Moscow		Russian Federation	121352
2	Moscow Clinical Hospital no.24	Moscow		Russian Federation	127015

Sponsors and Collaborators

• Pirogov Russian National Research Medical University
• Medtronic

Investigators

• Principal Investigator: Kirill Lobastov, PhD, Pirogov Russian National Research Medical University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 15, 2016

More Information

Publications

None provided.

• Responsible Party: Kirill Lobastov, Associated Professor, Pirogov Russian National Research Medical University
• ClinicalTrials.gov Identifier: NCT03044574
• Other Study ID Numbers: IPCSUPER
• First Posted: Feb 7, 2017
• Last Update Posted: Feb 4, 2021
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Kirill Lobastov, Associated Professor, Pirogov Russian National Research Medical University: venous thromboembolism; deep vein thrombosis; pulmonary embolism; prevention; intermittent pneumatic compression; sequential pneumatic compression; surgery; elastic compression; low-molecular weight heparin; prophylaxis
• Additional relevant MeSH terms: Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis

Study Results

Participant Flow

Recruitment Details	The total amount of 812 patients were screened during the enrollment period, 405 of them were excluded: Caprini score of <11 (n=304); a various regimen of anticoagulation (n=48); venous thrombosis at the baseline (n=31); declined participation (n=18); implanted inferior vena cava filter (n=4).

Arm/Group Title	Experimental Group (SCD + GCS + LMWH)	Control Group (GCS + LMWH)
Arm/Group Description	Sequential Compression Device (SCD): Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge. Graduated Compression Stockings (GCS): Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge Low-Molecular-Weight-Heparin (LMWH): LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.	GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
Period Title: Overall Study
STARTED	204	203
Inpatient Period	204	203
30 Days After Surgery	193	194
180 Days After Surgery	167	158
COMPLETED	167	158
NOT COMPLETED	37	45

Baseline Characteristics

Arm/Group Title	Experimental Group (SCD + GCS + LMWH)	Control Group (GCS + LMWH)	Total
Arm/Group Description	Sequential Compression Device (SCD): Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with a 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in the surgery department - all time of bed rest. SCD used until discharge. Graduated Compression Stockings (GCS): Thigh-length graduated compression stockings with a pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge Low-Molecular-Weight Heparin: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.	GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.	Total of all reporting groups
Overall Participants	204	203	407
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.8 (9.6)	68.8 (10.0)	68.8 (9.8)
Sex: Female, Male (Count of Participants)
Female	129 63.2%	118 58.1%	247 60.7%
Male	75 36.8%	85 41.9%	160 39.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Russia	204 100%	203 100%	407 100%
Surgical profile (Count of Participants)
Addominal surgery	131 64.2%	147 72.4%	278 68.3%
Non-abdominal surgery	73 35.8%	56 27.6%	129 31.7%
Malignancy (Count of Participants)
Count of Participants [Participants]	171 83.8%	165 81.3%	336 82.6%
Caprini score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	11.5 (1.8)	11.4 (1.9)	11.4 (1.9)
Number of patients with Caprini score of 11 and higher (Count of Participants)
Count of Participants [Participants]	145 71.1%	140 69%	285 70%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Asymptomatic Venous Thrombosis of Lower Limbs as Detected by Duplex Ultrasound
Description	Asymptomatic deep and/or superficial vein thrombosis of lower limbs detected by duplex ultrasound performed at baseline and then every 3-5 days after surgery until discharge.
Time Frame	time of discharge from the hospital or death, up to 45 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group (SCD + GCS + LMWH)	Control Group (GCS + LMWH)
Arm/Group Description	SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge. GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.	GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
Measure Participants	204	203
Count of Participants [Participants]	1 0.5%	34 16.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Group (SCD + GCS + LMWH), Control Group (GCS + LMWH)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments

2. Secondary Outcome

Title	Number of Patients With Proximal Deep Venous Thrombosis as Detected by Duplex Ultrasound
Description	Proximal deep vein thrombosis defined as thrombus of popliteal, femoral, iliac veins and/or inferior vena cava. Detected by duplex ultrasound performed at baseline and then every 3-5 days after surgery until discharge.
Time Frame	time of discharge from the hospital or death, up to 45 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group (SCD + GCS + LMWH)	Control Group (GCS + LMWH)
Arm/Group Description	SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge. GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.	GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
Measure Participants	204	203
Count of Participants [Participants]	0 0%	5 2.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Group (SCD + GCS + LMWH), Control Group (GCS + LMWH)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Fisher Exact
	Comments

3. Secondary Outcome

Title	Number of Patients With Isolated Calf Muscle Vein Thrombosis as Detected by Duplex Ultrasound
Description	Isolated calf muscle vein thrombosis was defined as thrombosis of soleal, gastrocnemius or other calf muscle veins not extended into tibial, or peroneal, or popliteal veins. Detected by duplex ultrasound performed at baseline and then every 3-5 days after surgery until discharge.
Time Frame	time of discharge from the hospital or death, up to 45 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group (SCD + GCS + LMWH)	Control Group (GCS + LMWH)
Arm/Group Description	SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge. GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.	GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
Measure Participants	204	203
Count of Participants [Participants]	1 0.5%	15 7.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Group (SCD + GCS + LMWH), Control Group (GCS + LMWH)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments

4. Secondary Outcome

Title	Number of Patients With Pulmonary Embolism
Description	Symptomatic pulmonary embolism (PE) that occurred during the inpatient period of treatment and confirmed by computed tomography pulmonary angiogram (CTPA) or single-photon emission computed tomography with computed tomography (SPECT/CT) or autopsy
Time Frame	time of discharge from the hospital or death, up to 45 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group (SCD + GCS + LMWH)	Control Group (GCS + LMWH)
Arm/Group Description	SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge. GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.	GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
Measure Participants	204	203
Count of Participants [Participants]	0 0%	5 2.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Group (SCD + GCS + LMWH), Control Group (GCS + LMWH)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Fisher Exact
	Comments

5. Secondary Outcome

Title	Number of Patients Died From Any Reason
Description	Inpatient postoperative mortality: number of patients died from any reason during the inpatient period of treatment
Time Frame	time of discharge from the hospital or death, up to 45 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group (SCD + GCS + LMWH)	Control Group (GCS + LMWH)
Arm/Group Description	SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge. GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.	GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
Measure Participants	204	203
Count of Participants [Participants]	6 2.9%	10 4.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Group (SCD + GCS + LMWH), Control Group (GCS + LMWH)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Fisher Exact
	Comments

6. Secondary Outcome

Title	Number of Patients With Leg Skin Injury
Description	Leg skin injury defined as any skin hyperemia, maceration, laceration, bubbles, erosion or ulceration in the zone of application for GCS and SCD on the lower limbs revealed by clinical inspection of the skin and soft tissues until discharge
Time Frame	time of discharge from the hospital or death, up to 45 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group (SCD + GCS + LMWH)	Control Group (GCS + LMWH)
Arm/Group Description	SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge. GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.	GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
Measure Participants	204	203
Count of Participants [Participants]	25 12.3%	15 7.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Group (SCD + GCS + LMWH), Control Group (GCS + LMWH)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Fisher Exact
	Comments

7. Secondary Outcome

Title	Number of Patients With Symptomatic and Asymptomatic VTE Events at 30 Days After Surgery
Description	Taking into account all VTE events: asymptomatic revealed by duplex ultrasound, symptomatic confirmed by duplex ultrasound, CTPA, SPECT/CT, autopsy in patients discharged from the hospital and still receiving inpatients care at 30 days after surgery.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group (SCD + GCS + LMWH)	Control Group (GCS + LMWH)
Arm/Group Description	SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge. GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.	GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
Measure Participants	193	194
Count of Participants [Participants]	1 0.5%	35 17.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Group (SCD + GCS + LMWH), Control Group (GCS + LMWH)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments

8. Secondary Outcome

Title	Number of Patients Who Died From VTE at 30 Days After Surgery
Description	VTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group (SCD + GCS + LMWH)	Control Group (GCS + LMWH)
Arm/Group Description	SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge. GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.	GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
Measure Participants	193	194
Count of Participants [Participants]	0 0%	2 1%

9. Secondary Outcome

Title	Number of Patients With Symptomatic and Asymptomatic VTE Events at 180 Days After Surgery
Description	Taking into account all symptomatic and asymptomatic VTE events confirmed by duplex ultrasound, CTPA, SPECT/CT, autopsy or other appropriate methods of diagnosis that occurred during the inpatient period of treatment and outpatient period of observation
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group (SCD + GCS + LMWH)	Control Group (GCS + LMWH)
Arm/Group Description	SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge. GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.	GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
Measure Participants	167	158
Count of Participants [Participants]	1 0.5%	35 17.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Group (SCD + GCS + LMWH), Control Group (GCS + LMWH)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments

10. Secondary Outcome

Title	Number of Patients Who Died From VTE at 180 Days After Surgery
Description	VTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group (SCD + GCS + LMWH)	Control Group (GCS + LMWH)
Arm/Group Description	SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge. GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.	GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
Measure Participants	167	158
Count of Participants [Participants]	0 0%	3 1.5%

11. Other Pre-specified Outcome

Title	Duration of Inpatient Period of Treatment
Description	The inpatient period of treatment suggests time from surgical intervention to discharge from the hospital or death.
Time Frame	time of discharge from the hospital or death, up to 45 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group (SCD + GCS + LMWH)	Control Group (GCS + LMWH)
Arm/Group Description	SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge. GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.	GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
Measure Participants	204	203
Median (Inter-Quartile Range) [days]	10	10

Adverse Events

Time Frame	30 days after surgery for most of the adverse events except all-cause mortality that reported over 6 months
Arm/Group Title	Experimental Group (SCD + GCS + LMWH)		Control Group (GCS + LMWH)
Arm/Group Description	SCD: Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge. GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.		GCS: Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge LMWH: LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
All Cause Mortality
	Experimental Group (SCD + GCS + LMWH)		Control Group (GCS + LMWH)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/204 (5.4%)		18/203 (8.9%)
Serious Adverse Events
	Experimental Group (SCD + GCS + LMWH)		Control Group (GCS + LMWH)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/204 (2.5%)		4/203 (2%)
Blood and lymphatic system disorders
Major bleeding	5/204 (2.5%)	5	4/203 (2%)	4
Other (Not Including Serious) Adverse Events
	Experimental Group (SCD + GCS + LMWH)		Control Group (GCS + LMWH)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	27/204 (13.2%)		22/203 (10.8%)
Blood and lymphatic system disorders
Clinical relevant non-major bleeding	2/204 (1%)	2	7/203 (3.4%)	7
Injury, poisoning and procedural complications
Skin hyperemia on lower limbs	18/204 (8.8%)	18	13/203 (6.4%)	13
Skin blisters on lower limbs	3/204 (1.5%)	3	1/203 (0.5%)	1
Skin necrosis on lower limbs	4/204 (2%)	4	1/203 (0.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.