PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT Pilot)

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canadian Critical Care Trials Group
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182364
First received: September 10, 2005
Last updated: November 16, 2006
Last verified: November 2006
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00182364

Locations
Australia
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
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
Hamilton Health Science Centre - McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton Health Science Centre - Henderson Hospital
Hamilton, Ontario, Canada, L8N 4A6
Ottawa General Hosptial
Ottawa, Ontario, Canada, K1H 8L6
Ottawa Civic Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sunnybrook & Women's College Health Science Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Hopital Charles LeMoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Sacre Couer
Montreal, Quebec, Canada, H4J 2C5
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada, H1T 2M4
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
Investigators
Principal Investigator: Deborah J Cook, MD McMaster University
  More Information

Publications:
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.

ClinicalTrials.gov Identifier: NCT00182364     History of Changes
Other Study ID Numbers: 54618366 PROTECT pilot, FGMAEI-0042-048
Study First Received: September 10, 2005
Last Updated: November 16, 2006
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Critical Illness
Thromboembolism
Thrombosis
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Disease Attributes
Embolism and Thrombosis
Pathologic Processes
Vascular Diseases
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014