Venous ThromboembolismPhase 3NCT00135876
Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients
A Phase 3 study testing dalteparin in people with Venous Thromboembolism and Brain Tumors, run by Ontario Clinical Oncology Group (OCOG) at 14 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Brain Tumors
- What is being tested?
- dalteparin
- How many people
- 512 participants
- Where
- 14 sitesin 4 countries
- Study dates
- Oct 2002to Nov 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
Canada6 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6
Toronto-Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
United States3 sites
Henry Ford Hospital
Detroit, Michigan, 48202
Kellogg Cancer Center - Evanston Northwestern Healthcare
Evanston, Illinois, 60201
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
Australia3 sites
The St. George Hospital
Kogarah, New South Wales, 2217
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Royal Perth Hospital
Perth, Western Australia, 6847
Italy2 sites
Ospedali Riuniti di Bergamo
Bergamo, 24128
Università di Perugia
Perugia, 06123
About this study
Official title: A Trial of Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients (PRODIGE)
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.
Read the 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.
- Conditions
- Venous Thromboembolism, Brain Tumors
- Being tested
- dalteparin
- Keywords
- deep vein thrombosis, pulmonary embolism, glioma, fragmin, anticoagulant, prophylaxis, dalteparin
- Medical subject headings
- Venous Thromboembolism, Brain Neoplasms, Venous Thrombosis, Pulmonary Embolism, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dalteparinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
objectively-proven symptomatic VTE (DVT or PE)
Secondary outcomes (4)
bleeding (major and all bleeding)
quality of life
cognition assessments
death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startOct 2002
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 512 participants
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- James Perry, MD, Study chair, Toronto Sunnybrook Regional Cancer CentreMark Levine, MD, Principal investigator, Ontario Clinical Oncology Group (OCOG)William Geerts, MD, Principal investigator, Toronto Sunnybrook Regional Cancer CentreJim Julian, MMath, Principal investigator, McMaster University, Dept of Clinical Epidemiology & Biostatistics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135876
- Sponsor's protocol ID
- 524E-CVD-0056-013
- Status last verified
- Apr 2007
- First submitted
- 24 Aug 2005
- Last updated
- 27 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients (PRODIGE)
- ClinicalTrials.gov ID
- NCT00135876
- Acronym / sponsor ID
- 524E-CVD-0056-013
- Conditions
- Venous Thromboembolism, Brain Tumors
- Keywords
- deep vein thrombosis, pulmonary embolism, glioma, fragmin, anticoagulant, prophylaxis, dalteparin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2002
- Study completion
- Nov 2006 (actual)
- First posted
- 26 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both of the following criteria must be satisfied:
Key exclusion criteria (17 listed)
- If one or more of the following criteria are satisfied, the patient is not eligible for the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dalteparin | Drug | – |
Primary outcome
objectively-proven symptomatic VTE (DVT or PE)
4 secondary outcomes
bleeding (major and all bleeding)
quality of life
cognition assessments
death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Perry, MD study chair
Toronto Sunnybrook Regional Cancer Centre
Mark Levine, MD principal investigator
Ontario Clinical Oncology Group (OCOG)
William Geerts, MD principal investigator
Toronto Sunnybrook Regional Cancer Centre
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dalteparin in people with Venous Thromboembolism and Brain Tumors, run by Ontario Clinical Oncology Group (OCOG) at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Canada, United States, Australia, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objectively-proven symptomatic VTE (DVT or PE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2007.