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PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT Pilot)

This study has been completed.
Canadian Institutes of Health Research (CIHR)
Canadian Critical Care Trials Group
Information provided by:
McMaster University Identifier:
First received: September 10, 2005
Last updated: November 16, 2006
Last verified: November 2006
PROTECT Pilot objective is to assess: 1) the feasibility of timely enrollment and complete, blinded study drug administration, 2) the bioaccumulation of LMWH in patients with acquired renal insufficiency and its association with bleeding, 3) the feasibility of scheduled twice weekly lower limb ultrasounds, and 4) recruitment rates for a future randomized trial.

Condition Intervention Phase
Critically Ill
Deep Venous Thrombosis
Drug: Fragmin (Dalteparin) LMWH verus Unfractionated Heparin (UFH)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT Pilot)

Resource links provided by NLM:

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • The primary outcome for the PROTECT Study is objectively confirmed proximal DVT (proven symptomatic or asymptomatic DVT) diagnosed by bilateral lower extremity compression ultrasound, confirmed by venography when possible.

Secondary Outcome Measures:
  • There are four secondary outcomes: 1) PE diagnosed by the PE Diagnosis algorithm, 2) bleeding, 3) anti-Xa levels associated with heparin dose adjustment, 4) thrombocytopenia and HIT

Estimated Enrollment: 120
Study Start Date: February 2003
Estimated Study Completion Date: February 2004
  Show Detailed Description


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

Inclusion Criteria:

  1. Admission to ICU
  2. Men and women greater than 18 years of age or older
  3. Expected to remain in ICU admission greater than 72 hours

Exclusion Criteria:

  1. Contraindications to LMWH or blood products
  2. Trauma, post orthopedic surgery, post cardiac surgery or post neurosurgery patients,
  3. Uncontrolled hypertension as defined by a systolic blood pressure > 180 mmHg or a diastolic blood pressure > 110 mmHg,
  4. Hemorrhagic stroke, DVT, PE or major hemorrhage on admission or within 3 months,
  5. Coagulopathy as defined by INR >2 times upper limit of normal [ULN], or PTT >2 times ULN,
  6. Renal insufficiency as defined by a creatinine clearance <30ml/min,
  7. A need for oral or intravenous or subcutaneous therapeutic anticoagulation,
  8. Heparin allergy, proven or suspected heparin-induced thrombocytopenia (HIT),
  9. Receipt of >2 doses of UFH or LMWH in ICU,
  10. Pregnant or lactating,
  11. Withdrawal of life support or limitation of life support,
  12. Prior enrollment in this trial
  13. Prior enrollment into a related RCT
  14. Thrombocytopenia defined platelet count < 100 x 109/L,
  15. Bilateral lower limb amputation,
  16. Allergy to pork or pork products
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00182364

Royal Alfred Hospital
Melbourne, Australia, 3181
Royal North Shore Hospital of Sydney
Sydney, Australia, 2065
Canada, Nova Scotia
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
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 Centre - Henderson Hospital
Hamilton, Ontario, Canada, L8N 4A6
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
Ottawa General Hosptial
Ottawa, Ontario, Canada, K1H 8L6
Ottawa Civic Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sunnybrook & Women's College Health Science Centre
Toronto, Ontario, Canada, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Hopital Charles LeMoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada, H1T 2M4
Hopital Sacre Couer
Montreal, Quebec, Canada, H4J 2C5
Centre Hospitalier Affilie- Enfant Jesus
Quebec City, Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
Canadian Critical Care Trials Group
Principal Investigator: Deborah J Cook, MD McMaster University
  More Information

McDonald E, Poirier G, Hebert P, Pagliarello J, Rocker G, Langevin S, LeBlanc F F, Mehta S, Skrobik Y, Fowler R, Granton J, Freitag A, Jones G, Cooper DJ, Meade M, Guyatt GH, Anderson D, Geerts W, Crowther M, Zytaruk N, Griffith LE, Cook DJ, for the PROTECT Investigators and Canadian Critical Care Trials Group. PROphylaxis for ThromboEmbolism in Critical care Trial. Blood 2004;104(ii):A1784.
Zytaruk N, Cook DJ, Meade M, Rocker G, Poirier G, Langevin S, LeBlanc F, Hebert P, Mehta S, Granton J, Freitag A, Guyatt GH, Anderson D, Geerts W, Crowther M, for the Canadian Critical Care Trials Group. Prophylaxis for thromboembolism in critical care trial: A pilot study. Am J Resp Crit Care Med 2004;169(7):A666.
McDonald E, Kho M, Wynne C, Duffet M, McNeil A, Provost L, Rioux A, LaRouche G, Davidson C, McCardle T, Watpool I, Foxall J, Lewis M, Pagliarello J, Jones G, Meade M, Crowther M, Rocker G, Cook DJ, for the Canadian Critical Care Trials Group. Multicenter RCT pilot studies: Exclusion criteria revisited. Am J Resp Crit Care Med 2004;169(7):A257.
Clarke F, McDonald E, Rocker G, Cook DJ. Research coordinator activities in the ICU: An observational study. Abstract #108. Crit Care Med 2004;31(12)(suppl):A26. Identifier: NCT00182364     History of Changes
Other Study ID Numbers: 54618366 PROTECT pilot
Study First Received: September 10, 2005
Last Updated: November 16, 2006

Keywords provided by McMaster University:
Critically Ill
Deep Venous Thrombosis
Randomized Control Trial
Pilot Study

Additional relevant MeSH terms:
Critical Illness
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017