Innohep for Prophylaxis of Venous Thromboembolism in Brain Tumor Patients

NCT00629447 | Completed

• 2 other identifiers: Pro000084864930
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Brain Tumor

Keywords

Primary Brain Tumor; Venous Thromboembolism; Heparin

Outcome Measures

Primary Outcomes (1)

• Neurologic evaluation, CBC, Coagulation test (PT w/ INR, aPTT),Karnofsky performance status, Thrombosis panel, Adverse events assessment

  MONTHS 2, 4, 6, 9, 12

Secondary Outcomes (1)

• Bone densitometry study (DEXA-Scan)d

  baseline and 12 months

Study Arms (1)

1

EXPERIMENTAL

The patients will receive a single daily subcutaneous injection of Tinzaparin at 4500 IU.

Drug: Innohep

Interventions

Innohep DRUG

The patients will receive a single daily subcutaneous injection of Tinzaparin at 4500 IU.

Also known as: Tinzaparin

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly diagnosed pathologically confirmed WHO Grade III or Grade IV glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, gliosarcoma and glioblastoma multiforme);
• Patients must be 18 years of age or older at the time of informed consent;
• Karnofsky performance status 60% and a life expectancy of at least 6 months;
• The patient is at least 48 hours after craniotomy or stereotactic biopsy but no later than four weeks from the last surgical procedure;
• Adequate hematologic function as demonstrated by laboratory values performed within 14 days: platelet count \> 100,000, prothrombin time (PT) 1.2 x control, inactivated partial thromboplastin time (aPTT) 1.2 x control;
• Signed informed consent prior to patient registration.

You may not qualify if:

• Presence of a coagulopathy, as defined by laboratory parameters including a platelet count \< 100,000, PT \> 1.2 x control or a PTT \> 1.2 x control.
• Symptomatic intracranial bleeding, which includes inter- or intratumor bleeding and causes mass effect or neurological disability control;
• The presence of acute or chronic deep venous thrombosis demonstrated by ultrasonography or venography. A baseline screening ultrasound or venogram is not required;
• Active systemic bleeding, such as gastrointestinal bleeding or gross hematuria;
• Excessive risk of bleeding as defined by stroke within the prior 6 months, history of CNS or intraocular bleed, or septic endocarditis;
• Prior history of documented DVT or PE;
• History of immune mediated heparin induced thrombocytopenia, as documented by a platelet count \< 50,000 and positive heparin-induced platelet aggregation test;
• Contraindication to tinzaparin or other heparins, including allergy or hypersensitivity to heparin or pork products, sulfite allergy, benzyl alcohol allergy or have or had had an epidural catheter or traumatic spinal puncture within 7 days prior to screening;
• Serum creatinine \>3.0 mg/dl;
• Patient or partner of childbearing potential and not using adequate contraception;
• Pregnant or nursing (women of childbearing potential may have a screening pregnancy test at the discretion of the investigator);
• Medical condition requiring long-term anticoagulants such as atrial fibrillation or a mechanical heart valve;
• Inability to give informed consent;
• Inability to comply with study procedures, including subcutaneous injections and diagnostic procedures;

Sponsors & Collaborators

• Duke University: lead
• Celgene Corporation: collaborator

Study Sites (1)

Duke University Health Systems

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Venous Thromboembolism

Interventions

Tinzaparin

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• James Vredenburgh, MD

  Duke University Heatlh Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 6, 2008
• Study Start: February 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: October 1, 2009
• Last Updated: January 7, 2013

Record last verified: 2013-01

Locations

US (1)