PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)

Not Applicable

Completed

• Conditions: Critical illness, deep vein thrombosis; Circulatory System; Phlebitis and thrombophlebitis

• Registration Number: ISRCTN94385648
• Lead Sponsor: Hamilton Health Sciences (Canada)

Brief Summary

1. 2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21417952 (added 10/04/2019) 2. 2011 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/21482348 (added 10/04/2019) 3. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23788287 (added 10/04/2019) 4. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23942857 (added 10/04/2019) 5. 2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24726205 (added 10/04/2019) 6. 2014 economic evaluation in: https://www.ncbi.nlm.nih.gov/pubmed/25528663 (added 10/04/2019) 7. 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26356708 (added 10/04/2019) 8. 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26921148 (added 10/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-21
• Study Completion: 2010-12-12
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.