PROTECT TRIAL

Introduction:

Venous thromboembolism (VTE), which includes both deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common complication of critical illness. Most thrombi are asymptomatic and are confined to the deep veins of the calf. However, with time, 20-30% of untreated calf vein thrombi extend proximally into the thigh, where, if untreated, they pose a 40 to 50% risk of PE. ICU patients are most prone to this complication. We need perfect guidelines and a large study, statistically significant, to prove the benefit of best preventive measures in the field of thromboembolism.

Objective:

To evaluate the effect of LMWH vs UFH on the primary outcome of proximal leg DVT diagnosed by compression, ultrasound and the secondary outcomes of PE, bleeding, HIT, and objectively confirmed venous thrombosis at any site.

Design:

ProspA centralized, computerized web-based or phone-in randomization system will ensure concealed randomization of all patients to dalteparin 5,000 IU daily or UFH 5,000 IU twice daily. SC to be administered for the duration of ICU study. Eligible patients in medical-surgical ICUs will be >18years old, weigh > 45 kg, have an expected ICU stay >72h, and be eligible to receive either UFH or LMWH thromboprophylaxis.  We will record bleeding, HIT, other venous thrombosis and complications. Bilateral proximal leg compression ultrasounds will be performed within 48h of ICU admission, twice weekly, and on suspicion of DVT. This is randomized stratified concealed blinded multicenter trial.

Relevance

The results of PROTECT will be used to develop evidence-based practice guidelines regarding the safety and efficacy of LMWH vs UFH for thromboprophylaxis in medical-surgical ICU patients around the world.

Principal Investigator: Lt. Col. Dr. Yasser Mandourah

Director, Department of Intensive Care Services

RMH, Riyadh

Coordinator: Dr. Nadeem Shaikh

Intensivist Cardiologist

RMH, Riyadh