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

NCT00135876 | Completed Phase 3

• 1 other identifier: 524E-CVD-0056-013
• Study Type: interventional
• Target: 512
• Locations: 4 countries
• Sites: 14

Brief 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.

Conditions

Venous Thromboembolism; Brain Tumors

Keywords

deep vein thrombosis; pulmonary embolism; glioma; fragmin; anticoagulant; prophylaxis; dalteparin

Outcome Measures

Primary Outcomes (1)

• objectively-proven symptomatic VTE (DVT or PE)

Secondary Outcomes (4)

• bleeding (major and all bleeding)

• quality of life

• cognition assessments

• death

Interventions

dalteparin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both of the following criteria must be satisfied:
• 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;
• Patients 18 years of age or older at time of randomization

You may not qualify if:

• If one or more of the following criteria are satisfied, the patient is not eligible for the study:
• The presence of acute or chronic DVT demonstrated by duplex ultrasonography (DUS) or venography. (Note: a screening DUS is not required for study entry);
• Inability to commence study drug within four weeks of original surgery or biopsy;
• Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within four weeks of potential study entry;
• Presence of a coagulopathy (e.g. INR \>1.5 or platelet count \< 100x109/L);
• Known acute (symptomatic or actively bleeding) gastroduodenal ulcer;
• Familial bleeding diathesis;
• Requiring long term anticoagulants for other reasons (e.g., mechanical heart valves, atrial fibrillation);
• Uncontrolled hypertension despite antihypertensive therapy;
• Significant renal failure (dependent on dialysis or creatinine of greater than three times upper limit of normal control);
• Prior history of documented DVT or PE;
• Allergy to anticoagulants (UFH, LMWH) including immune-mediated heparin-induced thrombocytopenia;
• Pregnant or of childbearing potential and not using adequate contraception;
• Geographically inaccessible for follow-up;
• Having an expected life span of less than 6 months;

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• Pfizer: collaborator

Study Sites (14)

Kellogg Cancer Center - Evanston Northwestern Healthcare

Evanston, Illinois, 60201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112-5550, United States

Location

The St. George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6847, Australia

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

The Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Toronto-Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Ospedali Riuniti di Bergamo

Bergamo, 24128, Italy

Location

Università di Perugia

Perugia, 06123, Italy

Location

MeSH Terms

Conditions

Venous Thromboembolism; Brain Neoplasms; Venous Thrombosis; Pulmonary Embolism; Glioma

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• James Perry, MD

  Toronto Sunnybrook Regional Cancer Centre

  STUDY CHAIR

• Mark Levine, MD

  Ontario Clinical Oncology Group (OCOG)

  PRINCIPAL INVESTIGATOR

• William Geerts, MD

  Toronto Sunnybrook Regional Cancer Centre

  PRINCIPAL INVESTIGATOR

• Jim Julian, MMath

  McMaster University, Dept of Clinical Epidemiology & Biostatistics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 24, 2005
• First Posted: August 26, 2005
• Study Start: October 1, 2002
• Study Completion: November 1, 2006
• Last Updated: April 27, 2007

Record last verified: 2007-04

Locations

US (3); IT (2); AU (3); CA (6)