PROphylaxis of ThromboEmbolism in Critical Care Trial (PROTECT)

Phase 3

Completed

• Conditions: Thromboembolism; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12606000090516
• Lead Sponsor: McMaster University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3650

Inclusion Criteria

Actual body weight >45 kgAdmission to ICU expected to be >72 hours durationEligible for either UFH or LWMH thromboprophylaxis.

Exclusion Criteria

Contraindication to prophylactic heparinNeurosurgery within last 3 monthsIschemic or hemorrhagic stroke within last 3 monthsIntracranial hemorrhage, within last 3 monthsSystolic blood pressure (SBP) > 180 mmHg, diastolic blood pressure > 110 mmHg for > 12 hours requiring vasoactive drug infusionMajor hemorrhage within the last week unless definitively treated (e.g., AAA repair)Coagulopathy (INR > 2 x ULN, or PTT > 2 x ULN)Thrombocytopenia (platelet count < 75 x 109/L)Other heparin contraindications (e.g., HIT, pregnancy)Contraindications to blood products (e.g., Jehovah’s Witness)Unable to perform lower limb ultrasound (e.g., severe distal extremity burns)Limitation of life support (life expectancy < 7 days, or palliative care Contamination (e.g., > 3 days of any UFH or LMWH prophylaxis during this ICU admission).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proximal DVT (symptomatic or asymptomatic DVT) diagnosed by bilateral lower extremity compression ultrasound.[Outcome measured: 48 hours of enrolment, twice weekly during ICU stay and upon suspicion of VTE.]

Secondary Outcome Measures

Name	Time	Method
1) pulmonary embolism (PE)[Measured during the ICU and hospital duration.];2) bleeding[Measured during the ICU and hospital duration.];3) Heparin Induced Thrombocytopenia (HIT)[Measured during the ICU and hospital duration.];4) other clinically suspected, objectively confirmed venous thrombosis.[Measured during the ICU and hospital duration.];As always in ICU studies, we will record ICU length of stay, ICU mortality, hospital length of stay and hospital mortality.[Measured during the ICU and hospital duration.]