DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients

Information source: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Venous Thromboembolism; Brain Tumors

Intervention: dalteparin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Ontario Clinical Oncology Group (OCOG)

Official(s) and/or principal investigator(s):
James Perry, MD, Study Chair, Affiliation: Toronto Sunnybrook Regional Cancer Centre
Mark Levine, MD, Principal Investigator, Affiliation: Ontario Clinical Oncology Group (OCOG)
William Geerts, MD, Principal Investigator, Affiliation: Toronto Sunnybrook Regional Cancer Centre
Jim Julian, MMath, Principal Investigator, Affiliation: McMaster University, Dept of Clinical Epidemiology & Biostatistics

Summary

In patients with malignant glioma, to determine the efficacy of prophylaxis with LMWH (dalteparin) compared to placebo, both commenced beyond the immediate postoperative period, for the prevention of VTE.

Clinical Details

Official title: A Trial of Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients (PRODIGE)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Primary outcome: objectively-proven symptomatic VTE (DVT or PE)

Secondary outcome:

bleeding (major and all bleeding)

quality of life

cognition assessments

death

Detailed description: Patients are randomized 1: 1 to receive dalteparin 5,000 anti-Xa units s. c. daily versus placebo s. c. daily. The primary outcome is VTE-free survival at 6 months. Progression free survival; overall survival, toxicity, and neurocognitive performance are secondary outcome measures.

Eligibility

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

Criteria:

Inclusion Criteria:

- Both of the following criteria must be satisfied:

1. Patients with newly-diagnosed pathologically-confirmed WHO Grade 3 or Grade 4 glioma (anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma, anaplastic oligodendroglioma, and anaplastic mixed glioma). Tumour histology is based on local pathology review only; 2. Patients 18 years of age or older at time of randomization Exclusion Criteria:

- If one or more of the following criteria are satisfied, the patient is not eligible

for the study: 1. The presence of acute or chronic DVT demonstrated by duplex ultrasonography (DUS) or venography. (Note: a screening DUS is not required for study entry); 2. Inability to commence study drug within four weeks of original surgery or biopsy; 3. Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within four weeks of potential study entry; 4. Presence of a coagulopathy (e. g. INR >1. 5 or platelet count < 100x109/L); 5. Symptomatic intracranial or intratumoural bleeding. (Note: post-operative imaging of the brain is not required for study entry. Asymptomatic “routine” post-operative blood products in a post-surgical cavity are not an exclusion; 6. Known acute (symptomatic or actively bleeding) gastroduodenal ulcer; 7. Familial bleeding diathesis; 8. Requiring long term anticoagulants for other reasons (e. g., mechanical heart valves, atrial fibrillation); 9. Uncontrolled hypertension despite antihypertensive therapy; 10. Significant renal failure (dependent on dialysis or creatinine of greater than three times upper limit of normal control); 11. Prior history of documented DVT or PE; 12. Allergy to anticoagulants (UFH, LMWH) including immune-mediated heparin-induced thrombocytopenia; 13. Pregnant or of childbearing potential and not using adequate contraception; 14. Geographically inaccessible for follow-up; 15. Having an expected life span of less than 6 months; 16. Body weight < 40 kg.

Locations and Contacts

Ospedali Riuniti di Bergamo, Bergamo 24128, Italy

Università di Perugia, Perugia 06123, Italy

Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada

Kellogg Cancer Center - Evanston Northwestern Healthcare, Evanston, Illinois 60201, United States

CancerCare Manitoba, Winnipeg, Manitoba R3E 0V9, Canada

Henry Ford Hospital, Detroit, Michigan 48202, United States

The St. George Hospital, Kogarah, New South Wales 2217, Australia

Nova Scotia Cancer Centre, Halifax, Nova Scotia B3H 1V7, Canada

The Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario K1H 8L6, Canada

Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada

Toronto-Sunnybrook Regional Cancer Centre, Toronto, Ontario M4N 3M5, Canada

Huntsman Cancer Institute, Salt Lake City, Utah 84112-5550, United States

Sir Charles Gairdner Hospital, Nedlands, Western Australia 6009, Australia

Royal Perth Hospital, Perth, Western Australia 6847, Australia

Additional Information

Starting date: October 2002
Last updated: April 25, 2007

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017