Aspirin Prophylaxis for Venous Thromboembolism in Glioblastoma
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|ClinicalTrials.gov Identifier: NCT00790452|
Recruitment Status : Terminated (Low accrual.)
First Posted : November 13, 2008
Results First Posted : December 8, 2011
Last Update Posted : December 8, 2011
To determine whether aspirin (ASA) can lower the incidence of Venous Thromboembolism(VTE) in patients with Glioblastoma (GBM).
To determine clinical and laboratory factors which are associated with increased risk of VTE
If it is determined that ASA reduces the incidence of VTE in patients with GBM, then to determine the clinical and laboratory factors which are associated with an increased benefit from the drug.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: Aspirin Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized Phase II Trial of Aspirin for Primary Prophylaxis of Venous Thromboembolism in Glioblastoma|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
Active Comparator: Group 1 (Aspirin)
Aspirin 325 mg/day orally
325 mg daily by mouth
Other Name: ASA
Placebo Comparator: Group 2 (Placebo)
Tablet daily by mouth
- Frequency of VTE Events [ Time Frame: VTE evaluation with study visits (4 weeks) for up to 2 years ]Occurrences of Venous Thromboembolism (VTE) events in each study arm of a randomized placebo controlled trial of aspirin in GBM Patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790452
|United States, Texas|
|The University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Victor A Levin, MD,BS||The University of Texas MD Anderson Cancer|