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PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)

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ClinicalTrials.gov Identifier: NCT00182143
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : January 10, 2011
Sponsor:
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

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Critical Illness Deep Venous Thrombosis Drug: LMWH (Fragmin, dalteparin) Drug: Unfractionated Heparin Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3659 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)
Study Start Date : May 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is >/= 18 years of age
  2. Actual body weight is >/= 45 kg
  3. Admission to ICU expected to be >/= 72 hours in duration

Exclusion Criteria:

  1. Neurosurgery within last 3 months
  2. Ischemic stroke within last 3 months
  3. Intracranial hemorrhage within last 3 months
  4. Systolic Blood Pressure >/= 180mm Hg, Diastolic Blood Pressure >/= 110mm Hg for >/= 12 hours requiring vasoactive drug infusion
  5. Major hemorrhage within last week unless definitively treated
  6. Coagulopathy as defined by INR >/= 2 times upper limit of normal [ULN], or PTT >/= 2 times ULN, at time of screening
  7. Thrombocytopenia defined as platelet count </= 75 x 109/L, at time of screening
  8. Other heparin contraindications (e.g., HIT, pregnancy, lactating)
  9. Contraindication to blood products (e.g., Jehovah's Witness)
  10. Unable to perform lower limb ultrasound (e.g., bilateral above the knee amputation, or severe distal extremity burns)
  11. Limitation of life support, Life expectancy </= 14 days, or palliative care
  12. Contamination (e.g., >/= 3 doses of LMWH during this ICU admission)
  13. Lack of informed consent
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182143


Locations
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Sponsors 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
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Principal Investigator: Deborah J Cook, MD McMaster University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT00182143    
Other Study ID Numbers: ISRCTN54618366
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: January 10, 2011
Last Verified: October 2007
Keywords provided by McMaster University:
Critically Ill
Deep Venous ThromboEmbolism
Randomized Controlled Trial
Additional relevant MeSH terms:
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Thrombosis
Thromboembolism
Venous Thrombosis
Critical Illness
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
 Heparin
Calcium heparin
Dalteparin
Tinzaparin
Heparin, Low-Molecular-Weight
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action