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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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;
Show all 17Show fewer
  • 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

Other trials in Canada

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

Other trials in United States

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

Other trials in Australia

Italy2 sites

  • Ospedali Riuniti di Bergamo

    Bergamo, 24128

  • Università di Perugia

    Perugia, 06123

Other trials in Italy

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.

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.

  1. objectively-proven symptomatic VTE (DVT or PE)

Secondary outcomes (4)

  1. bleeding (major and all bleeding)

  2. quality of life

  3. cognition assessments

  4. death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2005 (estimated)
  2. Study startOct 2002
  3. Study completionNov 2006

Resources

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
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

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?

On the ClinicalTrials.gov record for NCT00135876.

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.

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