A Pilot Trial of Innohep (Tinzaparin) Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumor Patients
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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Neurologic evaluation, CBC, Coagulation test (PT w/ INR, aPTT),Karnofsky performance status, Thrombosis panel, Adverse events assessment
MONTHS 2, 4, 6, 9, 12
James Vredenburgh, MD
Duke University Heatlh Systems
United States: Food and Drug Administration
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