A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients
Condition: Venous Thromboembolism; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism; Thromboembolism; Venous Thromboembolism
Intervention: dalteparin injection
Intervention description: 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).
Intervention MeSH terms: Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prevention of VTE and PE in high risk cancer patients

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-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.
    

Eligibility criteria:

        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