search
Back to results

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

Primary Purpose

Venous Thromboembolism, Brain Tumors

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
dalteparin
Sponsored by
Ontario Clinical Oncology Group (OCOG)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring deep vein thrombosis, pulmonary embolism, glioma, fragmin, anticoagulant, prophylaxis, dalteparin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Kellogg Cancer Center - Evanston Northwestern Healthcare
  • Henry Ford Hospital
  • Huntsman Cancer Institute
  • The St. George Hospital
  • Sir Charles Gairdner Hospital
  • Royal Perth Hospital
  • Cross Cancer Institute
  • CancerCare Manitoba
  • Nova Scotia Cancer Centre
  • The Ottawa Hospital Regional Cancer Centre
  • Toronto-Sunnybrook Regional Cancer Centre
  • Princess Margaret Hospital
  • Ospedali Riuniti di Bergamo
  • Università di Perugia

Outcomes

Primary Outcome Measures

objectively-proven symptomatic VTE (DVT or PE)

Secondary Outcome Measures

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

Full Information

First Posted
August 24, 2005
Last Updated
April 25, 2007
Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00135876
Brief Title
Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients
Official Title
A Trial of Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients (PRODIGE)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Brain Tumors
Keywords
deep vein thrombosis, pulmonary embolism, glioma, fragmin, anticoagulant, prophylaxis, dalteparin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
512 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dalteparin
Primary Outcome Measure Information:
Title
objectively-proven symptomatic VTE (DVT or PE)
Secondary Outcome Measure Information:
Title
bleeding (major and all bleeding)
Title
quality of life
Title
cognition assessments
Title
death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Perry, MD
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mark Levine, MD
Organizational Affiliation
Ontario Clinical Oncology Group (OCOG)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Geerts, MD
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jim Julian, MMath
Organizational Affiliation
McMaster University, Dept of Clinical Epidemiology & Biostatistics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kellogg Cancer Center - Evanston Northwestern Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5550
Country
United States
Facility Name
The St. George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6847
Country
Australia
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Nova Scotia Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
The Ottawa Hospital Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Toronto-Sunnybrook Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Ospedali Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
Università di Perugia
City
Perugia
ZIP/Postal Code
06123
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs