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Sponsors and Collaborators: |
University of Rochester National Heart, Lung, and Blood Institute (NHLBI) Eisai Medical Research Inc. |
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Information provided by: | University of Rochester |
ClinicalTrials.gov Identifier: | NCT00876915 |
Some cancer patients starting a new chemotherapy regimen are likely to develop blood clots, also known as venous thromboembolism (VTE). Blood clots can cause symptoms and can occasionally be life-threatening. The purpose of this study is to determine if a daily injection of a blood-thinner, dalteparin, for 12 weeks can safely and effectively reduce the frequency of blood clots. Dalteparin is currently approved for prevention of blood clots following surgery and in hospitalized patients but not specifically for cancer outpatients.
Condition | Intervention | Phase |
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Venous Thromboembolism Pulmonary Embolism |
Drug: dalteparin injection |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment |
Official Title: | A Prospective Randomized Multicenter Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients |
Estimated Enrollment: | 404 |
Study Start Date: | April 2009 |
Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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dalteparin injection: Experimental
Patients will be assigned at random to receive prophylactic dalteparin injections
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Drug: dalteparin injection
Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).
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No intervention: No Intervention
No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
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Drug: dalteparin injection
Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Charles Francis, MD | 585-275-3761 | Charles_Francis@URMC.Rochester.edu |
United States, New York | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
United States, North Carolina | |
Duke University School of Medicine | |
Durham, North Carolina, United States, 27705 |
Principal Investigator: | Charles W. Francis, MD | Univeristy of Rochester Medical Center |
Responsible Party: | University of Rochester ( Charles Francis, MD ) |
Study ID Numbers: | 25387, 1 R01 HL95109-01 |
Study First Received: | March 31, 2009 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00876915 History of Changes |
Health Authority: | United States: Institutional Review Board |
prevention of VTE and PE in high risk cancer patients |
Anticoagulants Pulmonary Embolism Heparin, Low-Molecular-Weight Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Venous Thromboembolism Thromboembolism Thrombosis |
Calcium heparin Fibrin Modulating Agents Embolism and Thrombosis Respiratory Tract Diseases Embolism Dalteparin Lung Diseases Heparin |
Anticoagulants Pulmonary Embolism Molecular Mechanisms of Pharmacological Action Hematologic Agents Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Venous Thromboembolism Pharmacologic Actions Thromboembolism |
Thrombosis Embolism and Thrombosis Fibrin Modulating Agents Respiratory Tract Diseases Embolism Dalteparin Therapeutic Uses Lung Diseases Cardiovascular Diseases |