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Sponsors and Collaborators: |
Hamilton Health Sciences Canadian Critical Care Trials Group Pfizer |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00138099 |
The investigators' primary research objective is:
To determine the safety of dalteparin prophylaxis, 5,000 IU once-daily, in Intensive Care Unit (ICU) patients based on:
The investigators' secondary research objectives are:
The DIRECT Pilot Study:
Before embarking on a large trial of low molecular weight heparin (LMWH) versus standard unfractionated heparin (UFH), the DIRECT Study is needed to observe whether bioaccumulation of LMWH occurs in ICU patients with moderate to severe renal insufficiency, and to address potential problems with protocol implementation.
Condition | Intervention | Phase |
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Renal Insufficiency |
Drug: Fragmin (dalteparin sodium) |
Phase II Phase III |
Study Type: | Observational |
Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
Official Title: | Dalteparin's Influence on Renally Compromised: Anti-Ten-A Study (DIRECT) |
Enrollment: | 140 |
Study Start Date: | July 2004 |
Study Completion Date: | June 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Nova Scotia | |
Queen Elizabeth II Health Science Centre | |
Halifax, Nova Scotia, Canada, B3H 3A7 | |
Canada, Ontario | |
St Joseph's HealthCare | |
Hamilton, Ontario, Canada, L8N 4A6 | |
Hamilton Health Science Centre - Hamilton General Hospital | |
Hamilton, Ontario, Canada, L8L 2X2 | |
Ottawa Civic Hospital | |
Ottawa, Ontario, Canada, K1Y 4E9 | |
University Health Network - Toronto General Hospital | |
Toronto, Ontario, Canada, M5G 2C4 | |
Hamilton Health Science Centre - Henderson Hospital | |
Hamilton, Ontario, Canada, L8V 1C3 | |
Hamilton Health Science Centre - McMaster University | |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Ottawa 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 | |
University Health Network - Toronto Western Hospital | |
Toronto, Ontario, Canada, M5G 2C4 | |
Canada, Quebec | |
Hopital Sacre Couer | |
Montreal, Quebec, Canada, H4J 2C5 | |
Hopital Maisonneuve Rosemont | |
Montreal, Quebec, Canada, H1T 2M4 | |
Hopital Charles LeMoyne | |
Greenfield Park, Quebec, Canada, J4V 2H1 |
Principal Investigator: | James Douketis, MD | McMaster University |
Principal Investigator: | Deborah J Cook, MD | McMaster University |
Study ID Numbers: | 092103, File No: 9427-M1133-21C, Control No: 092103 |
Study First Received: | August 29, 2005 |
Last Updated: | May 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00138099 History of Changes |
Health Authority: | Canada: Health Canada |
Critically ill patients (ICU) Deep Venous Thromboembolism prevention Renal Failure Critically ill |
Fibrin Modulating Agents Renal Insufficiency Anticoagulants Urologic Diseases Dalteparin Critical Illness |
Fibrinolytic Agents Cardiovascular Agents Kidney Diseases Venous Thromboembolism Thromboembolism Kidney Failure |
Fibrin Modulating Agents Renal Insufficiency Anticoagulants Molecular Mechanisms of Pharmacological Action Urologic Diseases Dalteparin |
Therapeutic Uses Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Kidney Diseases Pharmacologic Actions |