CompletedPhase 3Phase 4ACTRN12606000090516

PROphylaxis of ThromboEmbolism in Critical Care Trial (PROTECT)

A randomized phase III study to compare the effects of low-molecular weight heparin and unfractionated heparin in the prevention of proximal deep vein thrombosis in a critically ill population

Sponsor

McMaster University

Enrollment

3,650 participants

Start Date

May 16, 2006

Study Type

Interventional

Conditions

Thromboembolism

Summary

Patients will undergo concealed random allocation to either LMWH (dalteparin 5,000 IU once daily, the experimental intervention) or UFH (5,000 IU bid, the control intervention) subcutaneously. The control intervention represents standard thromboprophylaxis in Canada and Australia for these ICU patients, as we have documented in surveys [Cook 2001, Cooper 2005], cross-sectional studies [Cook 2001, Lacherade] and a longitudinal study [Cook 2003]. We will prepare LMWH syringes that contain 5,000 IU of dalteparin. UFH syringes will contain 5,000 IU of UFH. Syringes of LMWH and UFH will appear identical. Patients allocated to LMWH will also receive one placebo injection daily to maintain blinding. For patients allocated to LMWH, the first dose, or the morning dose in each study kit will always be placebo and nurses will administer the numbered doses sequentially. This is to optimize the likelihood that the patients enrolled later in the day into the LMWH arm will receive active drug on study day 1. Nurses will administer study drug at approximately 1100h (+1 hour) (placebo or UFH) and 2300h (+1 hour) (dalteparin or UFH). Study drug will be administered for the duration of the ICU stay. Bilateral proximal leg compression ultrasounds will be performed within 48hours of enrolment, twice weekly, and on suspicion of DVT.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying: PROphylaxis of ThromboEmbolism in Critical Care Trial (PROTECT). It may be open to adults aged 18 and older who meet certain criteria, including: Actual body weight >45 kgAdmission to ICU expected to be >72 hours durationEligible for either UFH or LWMH thromboprophylaxis. Participation typically involves medical assessments, possible treatment with the study intervention, and follow-up visits to track your health.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients will undergo concealed random allocation to LMWH (dalteparin 5,000 IU once daily, the experimental intervention) subcutaneously.

Patients will undergo concealed random allocation to LMWH (dalteparin 5,000 IU once daily, the experimental intervention) subcutaneously. The control intervention represents standard thromboprophylaxis in Canada and Australia for these ICU patients, as we have documented in surveys [Cook 2001, Cooper 2005], cross-sectional studies [Cook 2001, Lacherade] and a longitudinal study [Cook 2003]. We will prepare LMWH syringes that contain 5,000 IU of dalteparin. UFH syringes will contain 5,000 IU of UFH. Syringes of LMWH and UFH will appear identical. Patients allocated to LMWH will also receive one placebo injection daily to maintain blinding. For patients allocated to LMWH, the first dose, or the morning dose in each study kit will always be placebo and nurses will administer the numbered doses sequentially. This is to optimize the likelihood that the patients enrolled later in the day into the LMWH arm will receive active drug on study day 1. Nurses will administer study drug at approximately 1100h (+1 hour) (placebo or UFH) and 2300h (+1 hour) (dalteparin or UFH). Study drug will be administered for the duration of the ICU stay. Bilateral proximal leg compression ultrasounds will be performed within 48hours of enrolment, twice weekly, and on suspicion of DVT.