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

Sponsor

Ontario Clinical Oncology Group (OCOG) (Other)

Overall Status

Completed

CT.gov ID

NCT00135876

Collaborator

Pfizer (Industry)

512

Enrollment

Locations

Duration (Months)

36.6

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism Brain Tumors	Drug: dalteparin	Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2002

Actual Study Completion Date :

Nov 1, 2006

Outcome Measures

Primary Outcome Measures

objectively-proven symptomatic VTE (DVT or PE) []

Secondary Outcome Measures

bleeding (major and all bleeding) []
quality of life []
cognition assessments []
death []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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);
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;
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;
Body weight < 40 kg.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kellogg Cancer Center - Evanston Northwestern Healthcare	Evanston	Illinois	United States	60201
2	Henry Ford Hospital	Detroit	Michigan	United States	48202
3	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112-5550
4	The St. George Hospital	Kogarah	New South Wales	Australia	2217
5	Sir Charles Gairdner Hospital	Nedlands	Western Australia	Australia	6009
6	Royal Perth Hospital	Perth	Western Australia	Australia	6847
7	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
8	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
9	Nova Scotia Cancer Centre	Halifax	Nova Scotia	Canada	B3H 1V7
10	The Ottawa Hospital Regional Cancer Centre	Ottawa	Ontario	Canada	K1H 8L6
11	Toronto-Sunnybrook Regional Cancer Centre	Toronto	Ontario	Canada	M4N 3M5
12	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
13	Ospedali Riuniti di Bergamo	Bergamo		Italy	24128
14	Università di Perugia	Perugia		Italy	06123

Sponsors and Collaborators

Ontario Clinical Oncology Group (OCOG)
Pfizer

Investigators

Study Chair: James Perry, MD, Toronto Sunnybrook Regional Cancer Centre
Principal Investigator: 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