A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients
This trial is active, not recruiting.
|Conditions||venous thromboembolism, pulmonary embolism|
|Sponsor||University of Rochester|
|Collaborator||National Heart, Lung, and Blood Institute (NHLBI)|
|Start date||July 2009|
|End date||July 2014|
|Trial size||229 participants|
|Trial identifier||NCT00876915, 1 R01 HL95109-01, 25387|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Sacramento, CA||University of California, Davis||no longer recruiting|
|Buffalo, NY||Roswell Park Cancer Institute||no longer recruiting|
|Rochester, NY||Rochester General Hospital||no longer recruiting|
|Rochester, NY||University of Rochester Medical Center||no longer recruiting|
|Durham, NC||Duke University School of Medicine||no longer recruiting|
|Cleveland, OH||Cleveland Clinic||no longer recruiting|
|Ottawa, Canada||Ottawa Hospital Research Institute (OHRI)||no longer recruiting|
|Intervention model||parallel assignment|
To conduct a prospective, randomized clinical trial comparing the safety and efficacy of prophylaxis with dalteparin to no treatment in reducing VTE in high-risk ambulatory cancer patients initiating chemotherapy.
time frame: 12 weeks
To establish the value of tissue factor (TF) as a predictive marker for VTE in ambulatory cancer patients receiving chemotherapy.
time frame: baseline evaluation of tissue factor and then monthly for 4 months
Male or female participants at least 18 years old.
Inclusion Criteria: - A histologic diagnosis of malignancy; - At planned initiation of a new systemic chemotherapy regimen (including patients starting on first chemotherapy or patients previously treated but starting on a new regimen); - A risk score for VTE ≥3 [assign score of 2 for very high risk sites of cancer (stomach, pancreas), score of 1 for high risk site (lung, lymphoma, gynecologic, bladder, testicular) and score of 0 for all other sites], hemoglobin <10 g/dL or planned use of erythropoiesis stimulating agents, platelet count ≥350,000/mm3, total leukocyte count > 11,000/mm3 or body mass index ≥ 35 kg/m2]. Any counts meeting criteria drawn within 2 weeks prior to enrollment are considered acceptable. - Age 18 years or older - Provide written, informed consent. Exclusion Criteria: - Active bleeding or at high risk of serious bleeding complication in the opinion of the investigator - Diagnosis of primary brain tumor multiple myeloma, leukemia, or myelodysplastic syndrome - Planned stem cell transplant - Life expectancy < 6 months - Known allergy to heparin or LMWH - Patient or caregiver incapable of daily self-injection - Acute or chronic renal insufficiency with creatinine clearance < 30 mL/min - History of heparin-induced thrombocytopenia - Allergy to contrast agents - Pregnancy - Need for anticoagulant therapy - Platelet count < 75,000/mm3
|Official title||A Prospective Randomized Multicenter Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients|
|Principal investigator||Charles W. Francis, MD|
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