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

Information source: University of Rochester
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Venous Thromboembolism; Pulmonary Embolism

Intervention: dalteparin injection (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: University of Rochester

Official(s) and/or principal investigator(s):
Charles W. Francis, MD, Principal Investigator, Affiliation: Univeristy of Rochester Medical Center

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.

Clinical Details

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

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

Primary outcome: 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.

Secondary outcome: To establish the value of tissue factor (TF) as a predictive marker for VTE in ambulatory cancer patients receiving chemotherapy.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University of California, Davis, Sacramento, California 95817, United States

Roswell Park Cancer Institute, Buffalo, New York 14263, United States

Rochester General Hospital, Rochester, New York 14621, United States

University of Rochester Medical Center, Rochester, New York 14642, United States

Duke University School of Medicine, Durham, North Carolina 27705, United States

Cleveland Clinic, Cleveland, Ohio 44195, United States

Ottawa Hospital Research Institute (OHRI), Ottawa, Ontario K1H 8L6, Canada

Additional Information

Starting date: July 2009
Last updated: April 4, 2014

Page last updated: August 20, 2015

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