NCT00629447

Innohep for Prophylaxis of Venous Thromboembolism in Brain Tumor Patients

A Pilot Trial of Innohep (Tinzaparin) Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumor Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety of prophylaxis with Tinzaparin low molecular weight heparin in primary brain tumor patients. 2. To determine the incidence of deep venous thrombosis or pulmonary embolism in brain tumor patients who will be receiving Tinzaparin as primary prophylaxis. 3. To determine the overall survival of patients with malignant glioma who receive Tinzaparin. 4. To determine the bone density before and after prophylactic Tinzaparin.

Detailed description

Many patients with brain tumors develop thinning of the bones and weak bones, called osteoporosis. At baseline (or within 4 weeks of enrollment onto study) and 12 months the subject will have a bone densitometry study (DEXA-Scan) which is a test to determine bone density (the measure of the strength and thickness of bones) by using x-ray techniques. A single arm pilot trial will be performed with newly diagnosed pathologically confirmed malignant glioma patients. The patients will receive low molecular weight heparin (Tinzaparin), which will begin at least 48 hours after craniotomy or stereotactic biopsy, but no later than four weeks after the most recent surgery. The patients will receive a single daily subcutaneous injection of Tinzaparin at 4500 IU. The primary analysis will be conducted at six months and the safety will be determined by the incidence of clinically significant bleeding, ≥ grade III/IV CNS hemorrhage or grade II hemorrhage elsewhere. The Tinzaparin will be discontinued for any grade II or higher hemorrhage, except CNS hemorrhage and patients with asymptomatic CNS hemorrhage seen on a scan (grade III) at study entry will stay on Tinzaparin, except if the CNS hemorrhage expands or there is a new hemorrhage, in which case the Tinzaparin will be discontinued. For patients without a CNS hemorrhage at entry, a new asymptomatic CNS hemorrhage (grade III), or a CNS hemorrhage with symptoms (≥ grade IV) will result in discontinuation of the Tinzaparin. If the patient does not have any hemorrhage, the Tinzaparin will be continued for an additional six months with the second analysis performed at 12 months. Patients may stay on Innohep as long as they are benefiting and there are no adverse reactions necessitation stopping therapy. Patients will continue to having the same labs and clinical follow-up.

Conditions

• Primary Brain Tumor

Interventions

Type	Name	Description
DRUG	Innohep	The patients will receive a single daily subcutaneous injection of Tinzaparin at 4500 IU.

Timeline

• Start date: 2004-02-01
• Primary completion: 2007-03-01
• Completion: 2009-10-01
• First posted: 2008-03-06
• Last updated: 2013-01-07

Locations

1 site across 1 country: United States