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Chemoprophylaxis Plus Early Ambulation

Primary Purpose

Pulmonary Embolism, Thoracic Surgery

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Chemoprophylaxis with Low Molecular Weight Heparin (LMWH)
Sponsored by
Shen Lei
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Embolism focused on measuring Pulmonary embolism, Thoracic surgery, Thromboprophylaxis

Eligibility Criteria

14 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Pulmonary Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Thromboprophylaxis

Arm 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.

Outcomes

Primary Outcome Measures

Incidence of Postoperative Pulmonary Embolism (PE) in Surgical Thoracic Patients Under Currently Used PE Prevention Strategies.
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.
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.

Full Information

First Posted
February 25, 2019
Last Updated
October 5, 2021
Sponsor
Shen Lei
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1. Study Identification

Unique Protocol Identification Number
NCT03862755
Brief Title
Chemoprophylaxis Plus Early Ambulation
Official Title
Chemoprophylaxis Plus Early Ambulation Prevent Chinese Thoracic Surgery Patients From Pulmonary Embolism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
September 12, 2017 (Actual)
Study Completion Date
November 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shen Lei

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Thoracic Surgery
Keywords
Pulmonary embolism, Thoracic surgery, Thromboprophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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).
Masking
None (Open Label)
Allocation
N/A
Enrollment
581 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thromboprophylaxis
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Chemoprophylaxis with Low Molecular Weight Heparin (LMWH)
Other Intervention Name(s)
Early ambulation
Intervention 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).
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gening Jiang
Organizational Affiliation
Shanghai Pulmonary Hospital, Shanghai, China
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Chemoprophylaxis Plus Early Ambulation

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