PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)

• Register: ISRCTN
• Last refreshed on: 5 May 2019
• Main ID: ISRCTN94385648
• Date of registration: 21/05/2008
• Prospective Registration: No
• Primary sponsor: Hamilton Health Sciences (Canada)
• Public title: PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)
• Scientific title: Low molecular weight heparin (LMWH) (dalteparin) versus unfractionated heparin (UFH) for deep vein thrombosis (DVT) prevention: a randomised, concealed, stratified, placebo-controlled, blinded, parallel assignment trial
• Date of first enrolment: 01/05/2006
• Target sample size: 3650
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN94385648
• Study type: Interventional
• Study design: Interventional, randomised, double blind (subject, caregiver, investigator and outcomes assessor), placebo-controlled, parallel assignment, safety/efficacy study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Australia, Brazil, Canada, Saudi Arabia, United States of America

Contacts

• Name: Deborah Cook

Key inclusion & exclusion criteria

Inclusion criteria:
1. Admission to Intensive Care Unit (ICU)
2. Men or women greater than or equal to 18 years of age
3. Actual body weight greater than or equal to 45 kg
4. Admission to ICU expected to be greater than or equal to 72 hours in duration

Exclusion criteria:
1. Trauma, post-orthopedic surgery or post-neurosurgery patients
2. Uncontrolled hypertension (systolic greater than 180 mmHg or diastolic greater than 110 mmHg)
3. Major haemorrhage, haemorrhagic stroke, DVT or PE on admission or within last three months
4. Coagulopathy as defined by international normalised ratio (INR) greater than two times upper limit of normal [ULN], or partial thromboplastin time (PTT) greater than two times ULN
5. Thrombocytopenia defined as platelet count less than or equal to 75 x 10^9/L
6. Need for oral or intravenous or subcutaneous therapeutic anticoagulation
7. Receipt of greater than three days of UFH or LMWH in ICU
8. Contraindication to heparin (e.g., suspected HIT), blood products or pork products
9. Pregnant or lactating
10. Withdrawal of life support or limitation of life support
11. Current enrolment in this trial or a related trial
12. Lack of informed consent


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Critical illness, deep vein thrombosis
Circulatory System
Phlebitis and thrombophlebitis

Intervention(s)

1. Drug: LMWH (dalteparin), 5,000 IU daily and placebo
2. Unfractionated heparin (UFH), 5,000 IU twice daily

The followup duration is to hospital discharge (which will vary for each patient).

Primary Outcome(s)

To evaluate the effect of LMWH (dalteparin) versus UFH on the primary outcome of proximal leg DVT diagnosed by compression ultrasound. Time frame: while in ICU to a maximum of 90 days.

Secondary Outcome(s)

To evaluate the effect of LMWH (dalteparin) versus UFH on the secondary outcomes of PE, bleeding, HIT, and objectively confirmed venous thrombosis at any site. Time frame: while in ICU to a maximum of 90 days.

Secondary ID(s)

NCT00182143

MCT-78568; ACTRN12606000090516

Source(s) of Monetary Support

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-78568)

Ethics review

Status:
Approval date:
Contact:

1. Canada: Research Ethics Board of McMaster University, Hamilton, Ontario on the 21st November 2005 and 21st November 2007 (ref: 05-2572) 2. Australia: Ethics Committee of Alfred Hospital on the 1st December 2003 (initially) (ref: 181/03) and on the 9th January 2006 (ref: 236/05) 3. Brazil: Comitê de Ética, Santa Casa de Misericordian de Porto Alegre Hospital on the 27th July 2006 (ref: 1368/06) and the Comissâo Nacional de Ética em P

Results

• Results available: Yes
• Date Completed: 12/12/2010