This trial is active, not recruiting.

Conditions venous thromboembolism, pulmonary embolism
Treatment dalteparin injection
Phase phase 3
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

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection Fragmin
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 (LMWH)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).
(No Intervention)
No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

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

Additional Information

Official title A Prospective Randomized Multicenter Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients
Principal investigator Charles W. Francis, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by University of Rochester.