PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)
This study has been completed.
Sponsor:
McMaster University
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canadian Critical Care Trials Group
Australian and New Zealand Intensive Care Society Clinical Trials Group
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182143
First received: September 10, 2005
Last updated: January 7, 2011
Last verified: October 2007
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Purpose
The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.
| Condition | Intervention | Phase |
|---|---|---|
|
Critical Illness Deep Venous Thrombosis |
Drug: LMWH (Fragmin, dalteparin) Drug: Unfractionated Heparin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT) |
Resource links provided by NLM:
Further study details as provided by McMaster University:
Primary Outcome Measures:
- To evaluate the effect of LMWH (Fragmin, 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the effect of LMWH (Fragmin, 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 ] [ Designated as safety issue: No ]
| Enrollment: | 3659 |
| Study Start Date: | May 2006 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: LMWH (Fragmin, dalteparin)
Placebo dose (normal saline) = AM dose LMWH (Fragmin, dalteparin) 5000IU daily = PM dose
|
Drug: LMWH (Fragmin, dalteparin)
Placebo AM dose (normal saline) and LMWH (Fragmin, dalteparin) 5000IU PM dose
Other Name: Fragmin
|
|
Active Comparator: 2
Unfractionated Heparin 5000IU BID
|
Drug: Unfractionated Heparin
5000 IU BID
Other Name: Heparin Sodium
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient is >/= 18 years of age
- Actual body weight is >/= 45 kg
- Admission to ICU expected to be >/= 72 hours in duration
Exclusion Criteria:
- Neurosurgery within last 3 months
- Ischemic stroke within last 3 months
- Intracranial hemorrhage within last 3 months
- Systolic Blood Pressure >/= 180mm Hg, Diastolic Blood Pressure >/= 110mm Hg for >/= 12 hours requiring vasoactive drug infusion
- Major hemorrhage within last week unless definitively treated
- Coagulopathy as defined by INR >/= 2 times upper limit of normal [ULN], or PTT >/= 2 times ULN, at time of screening
- Thrombocytopenia defined as platelet count </= 75 x 109/L, at time of screening
- Other heparin contraindications (e.g., HIT, pregnancy, lactating)
- Contraindication to blood products (e.g., Jehovah's Witness)
- Unable to perform lower limb ultrasound (e.g., bilateral above the knee amputation, or severe distal extremity burns)
- Limitation of life support, Life expectancy </= 14 days, or palliative care
- Contamination (e.g., >/= 3 doses of LMWH during this ICU admission)
- Lack of informed consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182143
Show 67 Study Locations
Show 67 Study LocationsSponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Canadian Critical Care Trials Group
Australian and New Zealand Intensive Care Society Clinical Trials Group
Investigators
| Principal Investigator: | Deborah J Cook, MD | McMaster University |
More Information
Additional Information:
No publications provided by McMaster University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | McMaster University |
| ClinicalTrials.gov Identifier: | NCT00182143 History of Changes |
| Other Study ID Numbers: | ISRCTN54618366 |
| Study First Received: | September 10, 2005 |
| Last Updated: | January 7, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by McMaster University:
|
Critically Ill Deep Venous ThromboEmbolism Randomized Controlled Trial |
Additional relevant MeSH terms:
|
Critical Illness Thromboembolism Thrombosis Venous Thrombosis Venous Thromboembolism Disease Attributes Pathologic Processes Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Calcium heparin |
Heparin Heparin, Low-Molecular-Weight Dalteparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013