PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00182143
First received: September 10, 2005
Last updated: January 7, 2011
Last verified: October 2007
  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:

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182143

  Hide Study Locations
Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
MD Anderson
Houston, Texas, United States, 77030
Australia, New South Wales
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Nepean Hospital
Penrith, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia, 5112
Australia, Victoria
Flinders Hospital
Bedford Park, Victoria, Australia
Bendigo Health Care
Bendigo, Victoria, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Center
Clayton, Victoria, Australia
Dandenong Hospital
Dandenong, Victoria, Australia, 3168
Frankston Hospital
Frankston, Victoria, Australia
The Geelong Hospital
Geelong, Victoria, Australia, 3220
Austin Hill Hospital
Heidelburg, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia, 3181
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3101
Australia
Royal North Shore Hospital
St Leonards, Australia, NSW 2065
Brazil
Hospital Moinhos de Vento
Porto Alegre, Rs Cep, Brazil, 90035-001
Hospitalar Santa Casa
Porto Alegre, RS, Brazil, 90020-200
Hospital ProCardiaco
Rio de Janeiro, Brazil
UTI da Enfermaria de Clinical Medica do Hospital
Sao Paulo, Brazil
Hospital Coracao
Sao Paulo, Brazil
Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada, T2N 2T9
The Peter Lougheed Hospital
Calgary, Alberta, Canada, TiY 6J4
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
University of Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
Surry Memorial
Surrey, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
St Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Royal Columbian Hospital
Vancouver, British Columbia, Canada, V3L 3W4
Vancouver Island Health Authority
Victoria, British Columbia, Canada
Canada, Manitoba
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Nova Scotia
Queen Elizabeth II Health
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Guelph General Hospital
Guelph, Ontario, Canada
St Joseph's HealthCare
Hamilton, Ontario, Canada, L8N 4A6
Hamilton Health Science Centre - Hamilton General Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton Health Science Centre - McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton Health Science Center - Henderson Hospital
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Grand River Hospital
Kitchener, Ontario, Canada, N2G 1G3
London Health Science Center
London, Ontario, Canada
Lakeridge Health
Oshawa, Ontario, Canada
Ottawa Hospital - Civic Site
Ottawa, Ontario, Canada, K1Y 4E9
Ottawa Hospital - General Hospital
Ottawa, Ontario, Canada, K1H 8L6
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sunnybrook and Women's College Health Science Centre
Toronto, Ontario, Canada, M4N 3M5
St Michaels Hospital
Toronto, Ontario, Canada, M5B 1W8
University Health Network - Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Toronto General Hospital
Toronto, Ontario, Canada
Canada, Quebec
Hopital Charles LeMoyne
Montreal, Quebec, Canada, J4V 2H1
Hopital Sacre Couer
Montreal, Quebec, Canada, H4J 2C5
Montreal General Hospital, McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Royal Victoria Hospital, McGill University Health Center
Montreal, Quebec, Canada, H3A 1A1
Hopital Maisonneuve
Montreal, Quebec, Canada
Centre Hospitalier Affilie-Enfant Jesus
Quebec City, Quebec, Canada, G1J 1Z4
Sherbrooke University (CHUS) Hospital
Sherbrooke, Quebec, Canada, J1H 5N4
Canada
Hopital Laval
Quebec, Canada, G1V 4G5
Saudi Arabia
King Abdulaziz Medical City Hospital
Riyadh, Riyahd, Saudi Arabia, 11426
King Faisal Specialist & Research Center
Jeddah, Saudi Arabia
King Abdulaziz University Hospital
Jeddah, Saudi Arabia, 21418
King Fahad Medical City
Riyadh, Saudi Arabia
Riyadh Military Hospital
Riyadh, Saudi Arabia
United Kingdom
Guys and St Thomas Hospital
London, England, United Kingdom
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
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 April 17, 2014