PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT Pilot)
This study has been completed.
Sponsor:
Hamilton Health Sciences Corporation
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
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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:
- Admission to ICU
- Men and women greater than 18 years of age or older
- Expected to remain in ICU admission greater than 72 hours
Exclusion Criteria:
- Contraindications to LMWH or blood products
- Trauma, post orthopedic surgery, post cardiac surgery or post neurosurgery patients,
- Uncontrolled hypertension as defined by a systolic blood pressure > 180 mmHg or a diastolic blood pressure > 110 mmHg,
- Hemorrhagic stroke, DVT, PE or major hemorrhage on admission or within 3 months,
- Coagulopathy as defined by INR >2 times upper limit of normal [ULN], or PTT >2 times ULN,
- Renal insufficiency as defined by a creatinine clearance <30ml/min,
- A need for oral or intravenous or subcutaneous therapeutic anticoagulation,
- Heparin allergy, proven or suspected heparin-induced thrombocytopenia (HIT),
- Receipt of >2 doses of UFH or LMWH in ICU,
- Pregnant or lactating,
- Withdrawal of life support or limitation of life support,
- Prior enrollment in this trial
- Prior enrollment into a related RCT
- Thrombocytopenia defined platelet count < 100 x 109/L,
- Bilateral lower limb amputation,
- Allergy to pork or pork products
Contacts and Locations
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 | |
| St. Joseph's Hospital | |
| 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 Centre - Henderson Hospital | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Ottawa Civic Hospital | |
| Ottawa, Ontario, Canada, K1Y 4E9 | |
| Ottawa General Hosptial | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| 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 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
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 Thrombosis Venous Thromboembolism Disease Attributes Pathologic Processes Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Calcium heparin |
Heparin 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