Chemoprophylaxis Plus Early Ambulation

Sponsor
Shen Lei (Other)
Overall Status
Completed
CT.gov ID
NCT03862755
Collaborator
(none)
581
1
1
3.1
186.1

Study Details

Study Description

Brief Summary

Pulmonary embolism (PE) can be a devastating postoperative complication and the leading cause of mortality after thoracic surgery. PE together with deep venous thrombosis (DVT) is called venous thromboembolism (VTE), whereas PE caused much more serious situation than DVT. Huge amount of data have demonstrated that thromboprophylaxis after surgery is very important to prevent postoperative VTE, especially after orthopedic surgery and plaster surgery. Moreover, for thoracic surgery, American College of Chest Physicians (ACCP) has published prevention guidelines of VTE in non-orthopedic surgical patients and has been used widely, but unfortunately prophylaxis measures had often been underused in China. However, to be honest, there could be a big difference between Chinese and western populations, for example, what guidelines recommended thrombolysis therapy in diagnosed massive or sub-massive PE patients is tissue type plasminogen activator (t-PA) 100 mg, while in China 50 mg has the same effect. So investigators wanted to establish if the prophylaxis measures what they were using currently are suitable for Chinese thoracic surgical patients.

Condition or Disease Intervention/Treatment Phase
  • Drug: Chemoprophylaxis with Low Molecular Weight Heparin (LMWH)
Phase 4

Detailed Description

Investigators enrolled 598 patients who were sent to thoracic postoperative intensive care unit (ICU) ward right after surgery from August 8 to September 12 of 2017 and those patients stayed in ICU for at least 24 hours. Excluded non-lung surgery there were 581 lung surgery cases. Investigators adopted the Caprini VTE risk assessment model from Boston Medical Center (BMC) in United States of America (USA). According to different risk level, participants received different thromboprophylaxis strategies. Early ambulation alone was for patients at low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at moderate (Caprini 5-8) or high risk (Caprini ≥9). Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously one time a day no later than 24 hours after surgery. Early ambulation means activity out of bed no later than 24 hours after surgery. Thromboprophylaxis contraindication included chest tube drainage more than 500 ml or major bleeding during operation or surgeons refusing to use thromboprophylaxis because they thought that patients would benefit more from not performing early ambulation or chemoprophylaxis. Some patients received chemoprophylaxis after they moved back to regular ward out of ICU which was called late chemoprophylaxis which means more than 24 hours after surgery. All chemoprophylaxis were used only during hospitalization. When participants were discharged, no extended treatment prescribed. However, they were followed up twice on 30 days and 60 days after surgery by phone call.

Study Design

Study Type:
Interventional
Actual Enrollment :
581 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously one time a day no later than 24 hours after surgery. Early ambulation means activity out of bed no later than 24 hours after surgery. According to different risk level, patients received different thromboprophylaxis strategies. Early ambulation alone was for patients at low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at moderate (Caprini 5-8) or high risk (Caprini ≥9).Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously one time a day no later than 24 hours after surgery. Early ambulation means activity out of bed no later than 24 hours after surgery. According to different risk level, patients received different thromboprophylaxis strategies. Early ambulation alone was for patients at low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at moderate (Caprini 5-8) or high risk (Caprini ≥9).
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Chemoprophylaxis Plus Early Ambulation Prevent Chinese Thoracic Surgery Patients From Pulmonary Embolism
Actual Study Start Date :
Aug 8, 2017
Actual Primary Completion Date :
Sep 12, 2017
Actual Study Completion Date :
Nov 11, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Thromboprophylaxis

All surgical patients classified into low risk and moderate/high risk groups based on Caprini score and received different thromboprophylaxis strategies Briefly, early ambulation alone was used in patients at low risk, early ambulation plus chemoprophylaxis with Low Molecular Weight Heparin was used in patients at moderate/high risk.

Drug: Chemoprophylaxis with Low Molecular Weight Heparin (LMWH)
Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously one time a day no later than 24 hours after surgery. Early ambulation means activity out of bed no later than 24 hours after surgery. According to different risk level, patients received different thromboprophylaxis strategies. Early ambulation alone was for patients at low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at moderate (Caprini 5-8) or high risk (Caprini ≥9).
Other Names:
  • Early ambulation
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence of Postoperative Pulmonary Embolism (PE) in Surgical Thoracic Patients Under Currently Used PE Prevention Strategies. [up to 8 weeks post operation]

      Real number of PE cases are recorded. PE cases are confirmed by computed tomographic pulmonary angiography (CTPA). During hospitalization, on postoperative 30 days and 60 days, PE incidence is recorded and compared with that of some retrospective patients group. Investigators will study if currently used prevention strategies are effective to prevent PE.

    Secondary Outcome Measures

    1. Provider Adherence in Implementation of PE Prevention Strategies. [Through study completion, an average of 1 month]

      Since thromboprophylaxis is often underused in China, investigators want to investigate provider adherence in complying with thromboprophylaxis implementation. Some provider, mainly surgeon, don't comply with currently used prevention strategies. Based on real prevention methods that patients have received during postoperative period, provider adherence are shown as percentage. When analyzing data, investigators need to exclude those patients who didn't receive proper prevention according to our guidelines from whole patients group. By studying adherence outcome, investigators will know in what extent the surgeon's decision will influence the result.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Lung surgical patients who were sent to thoracic postoperative intensive care unit (ICU) ward right after surgery and stayed in ICU for at least 24 hours.
    Exclusion Criteria:
    • Cases received inferior vena filter and anti-coagulation treatment history.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Pulmonary Hospital Shanghai Shanghai China 200433

    Sponsors and Collaborators

    • Shen Lei

    Investigators

    • Study Chair: Gening Jiang, Shanghai Pulmonary Hospital, Shanghai, China

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Shen Lei, Clinical Associated Professor, Shanghai Pulmonary Hospital, Shanghai, China
    ClinicalTrials.gov Identifier:
    NCT03862755
    Other Study ID Numbers:
    • PE Prevention in SPH
    First Posted:
    Mar 5, 2019
    Last Update Posted:
    Nov 2, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Shen Lei, Clinical Associated Professor, Shanghai Pulmonary Hospital, Shanghai, China
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Thromboprophylaxis
    Arm/Group Description All surgical patients classified into low risk and moderate/high risk groups based on Caprini score and received different thromboprophylaxis strategies Briefly, early ambulation alone was used in patients at low risk, early ambulation plus chemoprophylaxis with Low Molecular Weight Heparin was used in patients at moderate/high risk. Chemoprophylaxis with Low Molecular Weight Heparin (LMWH): Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously QD no later than 24 hours after surgery. Early ambulation means activity out of bed no later than 24 hours after surgery. According to different risk level, patients received different thromboprophylaxis strategies. Early ambulation alone was for patients at low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at moderate (Caprini 5-8) or high risk (Caprini ≥9).
    Period Title: Overall Study
    STARTED 581
    COMPLETED 581
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Thromboprophylaxis
    Arm/Group Description All surgical patients classified into low risk and moderate/high risk groups based on Caprini score and received different thromboprophylaxis strategies Briefly, early ambulation alone was used in patients at low risk, early ambulation plus chemoprophylaxis with Low Molecular Weight Heparin was used in patients at moderate/high risk. Chemoprophylaxis with Low Molecular Weight Heparin (LMWH): Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously QD no later than 24 hours after surgery. Early ambulation means activity out of bed no later than 24 hours after surgery. According to different risk level, patients received different thromboprophylaxis strategies. Early ambulation alone was for patients at low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at moderate (Caprini 5-8) or high risk (Caprini ≥9).
    Overall Participants 581
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    58.8
    (11.2)
    Sex: Female, Male (Count of Participants)
    Female
    293
    50.4%
    Male
    288
    49.6%
    Race and Ethnicity Not Collected (Count of Participants)
    Region of Enrollment (participants) [Number]
    China
    581
    100%
    Body mass index (kg/m2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m2]
    23.3
    (3.2)
    Pathologic diagnosis (participants) [Number]
    Malignant
    433
    74.5%
    Benign
    148
    25.5%
    Surgical procedure (participants) [Number]
    Sub-lobar resections
    188
    32.4%
    Lobectomy
    368
    63.3%
    Extended Lobectomy
    25
    4.3%
    Length of ICU stay (days) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [days]
    1.2
    (0.6)
    Length of Hospital Stay (days) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [days]
    8.8
    (3.6)

    Outcome Measures

    1. Primary Outcome
    Title Incidence of Postoperative Pulmonary Embolism (PE) in Surgical Thoracic Patients Under Currently Used PE Prevention Strategies.
    Description Real number of PE cases are recorded. PE cases are confirmed by computed tomographic pulmonary angiography (CTPA). During hospitalization, on postoperative 30 days and 60 days, PE incidence is recorded and compared with that of some retrospective patients group. Investigators will study if currently used prevention strategies are effective to prevent PE.
    Time Frame up to 8 weeks post operation

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Thromboprophylaxis
    Arm/Group Description All surgical patients classified into low risk and moderate/high risk groups based on Caprini score and received different thromboprophylaxis strategies Briefly, early ambulation alone was used in patients at low risk, early ambulation plus chemoprophylaxis with Low Molecular Weight Heparin was used in patients at moderate/high risk. Chemoprophylaxis with Low Molecular Weight Heparin (LMWH): Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously QD no later than 24 hours after surgery. Early ambulation means activity out of bed no later than 24 hours after surgery. According to different risk level, patients received different thromboprophylaxis strategies. Early ambulation alone was for patients at low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at moderate (Caprini 5-8) or high risk (Caprini ≥9).
    Measure Participants 581
    Count of Participants [Participants]
    3
    0.5%
    2. Secondary Outcome
    Title Provider Adherence in Implementation of PE Prevention Strategies.
    Description Since thromboprophylaxis is often underused in China, investigators want to investigate provider adherence in complying with thromboprophylaxis implementation. Some provider, mainly surgeon, don't comply with currently used prevention strategies. Based on real prevention methods that patients have received during postoperative period, provider adherence are shown as percentage. When analyzing data, investigators need to exclude those patients who didn't receive proper prevention according to our guidelines from whole patients group. By studying adherence outcome, investigators will know in what extent the surgeon's decision will influence the result.
    Time Frame Through study completion, an average of 1 month

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Thromboprophylaxis
    Arm/Group Description All surgical patients classified into low risk and moderate/high risk groups based on Caprini score and received different thromboprophylaxis strategies Briefly, early ambulation alone was used in patients at low risk, early ambulation plus chemoprophylaxis with Low Molecular Weight Heparin was used in patients at moderate/high risk. Chemoprophylaxis with Low Molecular Weight Heparin (LMWH): Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously QD no later than 24 hours after surgery. Early ambulation means activity out of bed no later than 24 hours after surgery. According to different risk level, patients received different thromboprophylaxis strategies. Early ambulation alone was for patients at low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at moderate (Caprini 5-8) or high risk (Caprini ≥9).
    Measure Participants 581
    Compliance
    306
    52.7%
    Non-compliance
    275
    47.3%

    Adverse Events

    Time Frame until 2 days from the last intake of LMWH, an average of 72 hours
    Adverse Event Reporting Description Major bleeding
    Arm/Group Title Thromboprophylaxis
    Arm/Group Description All surgical patients classified into low risk and moderate/high risk groups based on Caprini score and received different thromboprophylaxis strategies Briefly, early ambulation alone was used in patients at low risk, early ambulation plus chemoprophylaxis with Low Molecular Weight Heparin was used in patients at moderate/high risk. Chemoprophylaxis with Low Molecular Weight Heparin (LMWH): Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously QD no later than 24 hours after surgery. Early ambulation means activity out of bed no later than 24 hours after surgery. According to different risk level, patients received different thromboprophylaxis strategies. Early ambulation alone was for patients at low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at moderate (Caprini 5-8) or high risk (Caprini ≥9).
    All Cause Mortality
    Thromboprophylaxis
    Affected / at Risk (%) # Events
    Total 1/581 (0.2%)
    Serious Adverse Events
    Thromboprophylaxis
    Affected / at Risk (%) # Events
    Total 0/581 (0%)
    Other (Not Including Serious) Adverse Events
    Thromboprophylaxis
    Affected / at Risk (%) # Events
    Total 0/581 (0%)

    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.

    Results Point of Contact

    Name/Title Dr. Lei Shen
    Organization Shanghai Pulmonary Hospital
    Phone 86-21-65115006 ext 2054
    Email sh_leisen@126.com
    Responsible Party:
    Shen Lei, Clinical Associated Professor, Shanghai Pulmonary Hospital, Shanghai, China
    ClinicalTrials.gov Identifier:
    NCT03862755
    Other Study ID Numbers:
    • PE Prevention in SPH
    First Posted:
    Mar 5, 2019
    Last Update Posted:
    Nov 2, 2021
    Last Verified:
    Oct 1, 2021