Status:
TERMINATED
A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Eisai Inc.
Conditions:
Venous Thromboembolism
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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-thre...
Detailed Description
VTE is an increasingly frequent complication of cancer and anti-cancer therapies. It is associated with increased mortality and other significant adverse consequences. Risk factors for VTE in the canc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT00876915
Start Date
July 1 2009
End Date
December 1 2014
Last Update
November 24 2015
Active Locations (7)
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1
University of California, Davis
Sacramento, California, United States, 95817
2
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
3
Rochester General Hospital
Rochester, New York, United States, 14621
4
University of Rochester Medical Center
Rochester, New York, United States, 14642