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Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a
Yaseen Arabi1, Fahad Al-Hameed2, Karen E A Burns3
1King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia. arabi@ngha.med.sa.
Trials
|March 17, 2018
Summary
The PREVENT trial investigates if intermittent pneumatic compression (IPC) reduces venous thromboembolism (VTE) in critically ill adults. This study aims to determine if adding IPC to standard treatment lowers deep vein thrombosis (DVT) rates.
Area of Science:
- Critical care medicine
- Vascular surgery
- Clinical trials
Background:
- Venous thromboembolism (VTE) is a significant risk in critically ill patients.
- Pharmacologic thromboprophylaxis is standard care, but VTE remains a concern.
- Intermittent pneumatic compression (IPC) is a potential adjunctive therapy.
Purpose of the Study:
- To evaluate the efficacy of adjunctive intermittent pneumatic compression (IPC) in preventing venous thromboembolism (VTE).
- To compare VTE rates in critically ill adults receiving IPC plus pharmacologic thromboprophylaxis versus pharmacologic thromboprophylaxis alone.
Main Methods:
- Multicenter randomized trial comparing IPC plus pharmacologic thromboprophylaxis to pharmacologic thromboprophylaxis alone.
- Primary outcome: incident proximal lower-extremity deep vein thrombosis (DVT) within 28 days.
- Blinded ultrasonography interpretation; unblinded patient and treatment teams.
Main Results:
- The study was powered to detect a 3% absolute risk reduction in proximal DVT.
- Specific results on the primary outcome are pending trial completion and analysis.
Conclusions:
- A detailed statistical analysis plan has been developed for the PREVENT trial.
- This plan ensures unbiased evaluation of primary and secondary outcomes.
- Adherence to the plan will facilitate robust interpretation of trial data.
Keywords:
Adjunct mechanical and pharmacologic DVT prophylaxisCritically-ill patientsDeep vein thrombosisIntermittent pneumatic compressionPulmonary embolismMore Related Videos
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