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A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients
This study is not yet open for participant recruitment.
Verified by University of Rochester, April 2009
First Received: March 31, 2009   Last Updated: April 3, 2009   History of Changes
Sponsors and Collaborators: University of Rochester
National Heart, Lung, and Blood Institute (NHLBI)
Eisai Medical Research Inc.
Information provided by: University of Rochester
ClinicalTrials.gov Identifier: NCT00876915
  Purpose

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.


Condition Intervention Phase
Venous Thromboembolism
Pulmonary Embolism
Drug: dalteparin injection
Phase III

MedlinePlus related topics: Cancer Pulmonary Embolism
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Parallel Assignment
Official Title: A Prospective Randomized Multicenter Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 404
Study Start Date: April 2009
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
dalteparin injection: Experimental
Patients will be assigned at random to receive prophylactic dalteparin injections
Drug: dalteparin injection
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 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 Intervention
No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
Drug: dalteparin injection
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 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876915

Contacts
Contact: Charles Francis, MD 585-275-3761 Charles_Francis@URMC.Rochester.edu

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Duke University School of Medicine
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
University of Rochester
Eisai Medical Research Inc.
Investigators
Principal Investigator: Charles W. Francis, MD Univeristy of Rochester Medical Center
  More Information

No publications provided

Responsible Party: University of Rochester ( Charles Francis, MD )
Study ID Numbers: 25387, 1 R01 HL95109-01
Study First Received: March 31, 2009
Last Updated: April 3, 2009
ClinicalTrials.gov Identifier: NCT00876915     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
prevention of VTE and PE in high risk cancer patients

Study placed in the following topic categories:
Anticoagulants
Pulmonary Embolism
Heparin, Low-Molecular-Weight
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Venous Thromboembolism
Thromboembolism
Thrombosis
Calcium heparin
Fibrin Modulating Agents
Embolism and Thrombosis
Respiratory Tract Diseases
Embolism
Dalteparin
Lung Diseases
Heparin

Additional relevant MeSH terms:
Anticoagulants
Pulmonary Embolism
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Venous Thromboembolism
Pharmacologic Actions
Thromboembolism
Thrombosis
Embolism and Thrombosis
Fibrin Modulating Agents
Respiratory Tract Diseases
Embolism
Dalteparin
Therapeutic Uses
Lung Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009