A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients
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.
Checked against the public recordLast updated Nov 24, 2015 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Prevention
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- University of Rochester
- Interventions being studied
- Drug: dalteparin injection
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of California, DavisSacramento, California
- Roswell Park Cancer InstituteBuffalo, New York
- Rochester General HospitalRochester, New York
- University of Rochester Medical CenterRochester, New York
- Duke University School of MedicineDurham, North Carolina
- Cleveland ClinicCleveland, Ohio
- Ottawa Hospital Research Institute (OHRI)Ottawa, Ontario
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 24, 2015. Always confirm current availability with the study team.