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A Prospective Randomized Multicenter Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Venous Thromboembolism, Pulmonary Embolism

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Trial Information

A Prospective Randomized Multicenter Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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.

Outcome Time Frame:

12 weeks

Safety Issue:

Yes

Principal Investigator

Charles W. Francis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Univeristy of Rochester Medical Center

Authority:

United States: Institutional Review Board

Study ID:

25387

NCT ID:

NCT00876915

Start Date:

July 2009

Completion Date:

Related Keywords:

  • Venous Thromboembolism
  • Pulmonary Embolism
  • prevention of VTE and PE in high risk cancer patients
  • Embolism
  • Pulmonary Embolism
  • Thromboembolism
  • Venous Thromboembolism
  • Venous Thrombosis

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Rochester Medical CenterRochester, New York  14642
Rochester General HospitalRochester, New York  14621
Duke University School of MedicineDurham, North Carolina  27710
University of California, DavisSacramento, California  95818