Chemoprophylaxis Plus Early Ambulation
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 |
---|---|---|
|
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
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:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
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.- PE Prevention in SPH
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
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%
|
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
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 |
sh_leisen@126.com |
- PE Prevention in SPH