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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00135876




Registration number
NCT00135876
Ethics application status
Date submitted
24/08/2005
Date registered
26/08/2005
Date last updated
27/04/2007

Titles & IDs
Public title
Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients
Scientific title
A Trial of Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients (PRODIGE)
Secondary ID [1] 0 0
524E-CVD-0056-013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 0 0
Brain Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - dalteparin

Treatment: Drugs: dalteparin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
objectively-proven symptomatic VTE (DVT or PE)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
bleeding (major and all bleeding)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
quality of life
Timepoint [2] 0 0
Secondary outcome [3] 0 0
cognition assessments
Timepoint [3] 0 0
Secondary outcome [4] 0 0
death
Timepoint [4] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
The St. George Hospital - Kogarah
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
6847 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Utah
Country [4] 0 0
Canada
State/province [4] 0 0
Alberta
Country [5] 0 0
Canada
State/province [5] 0 0
Manitoba
Country [6] 0 0
Canada
State/province [6] 0 0
Nova Scotia
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Italy
State/province [8] 0 0
Bergamo
Country [9] 0 0
Italy
State/province [9] 0 0
Perugia

Funding & Sponsors
Primary sponsor type
Other
Name
Ontario Clinical Oncology Group (OCOG)
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00135876
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Perry, MD
Address 0 0
Toronto Sunnybrook Regional Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00135876