CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 581 enrolled
Drug / intervention
Chemoprophylaxis with Low Molecular Weight Heparin (LMWH)drug
Likely dose
Chemoprophylaxis with Low Molecular Weight Heparin (LMWH) 3075 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03862755
NCT03862755Phase 4Completed

Chemoprophylaxis Plus Early Ambulation Prevent Chinese Thoracic Surgery Patients From Pulmonary Embolism

Shen Lei·interventional·Posted Mar 5, 2019·Updated Nov 2, 2021

In Brief

A Phase 4 clinical trial evaluating Chemoprophylaxis with Low Molecular Weight Heparin (LMWH) for Pulmonary Embolism and Thoracic Surgery. Completed, enrolled 581 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMar 5, 2019
Enrollment StartAug 8, 2017
Primary CompletionSep 12, 2017
Study CompletionNov 11, 2017
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 7.3 years ago

Interventions

Chemoprophylaxis with Low Molecular Weight Heparin (LMWH)drug

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).