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Aspirin Prophylaxis for Venous Thromboembolism in Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Glioblastoma
Interventions Drug: Aspirin
Drug: Placebo
Enrollment 1
Recruitment Details Recruitment Period: October 28, 2008 to October 26, 2009. All patient recruitment attempted to UT MD Anderson Cancer Center.
Pre-assignment Details The only participant enrolled was removed from the study due to a drug supply issue, and the study terminated early.
Arm/Group Title Group 1 (Aspirin) Group 2 (Placebo)
Hide Arm/Group Description Aspirin 325 mg/day orally Tablet/day orally
Period Title: Overall Study
Started 1 0
Completed 0 0
Not Completed 1 0
Reason Not Completed
Drug supply issue             1             0
Arm/Group Title Group 1 (Aspirin) Group 2 (Placebo) Total
Hide Arm/Group Description Aspirin 325 mg/day orally Tablet/day orally Total of all reporting groups
Overall Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants 0 participants 1 participants
53
(53 to 53)
53
(53 to 53)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female 1 1
Male 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 0 participants 1 participants
1 1
1.Primary Outcome
Title Frequency of VTE Events
Hide Description Occurrences of Venous Thromboembolism (VTE) events in each study arm of a randomized placebo controlled trial of aspirin in GBM Patients.
Time Frame VTE evaluation with study visits (4 weeks) for up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was to be per protocol, study terminated early with no analysis. Only enrolled participant to the study was prematurely taken off the study due to a drug supply issue.
Arm/Group Title Group 1 (Aspirin) Group 2 (Placebo)
Hide Arm/Group Description:
Aspirin 325 mg/day orally
Tablet/day orally
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 (Aspirin) Group 2 (Placebo)
Hide Arm/Group Description Aspirin 325 mg/day orally Tablet/day orally
All-Cause Mortality
Group 1 (Aspirin) Group 2 (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Group 1 (Aspirin) Group 2 (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1 (Aspirin) Group 2 (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Study terminated early due due to a drug supply issue.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Victor A Levin, MD, BS / Professor
Organization: UT MD Anderson Cancer Center
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00790452    
Other Study ID Numbers: 2007-0266
First Submitted: November 7, 2008
First Posted: November 13, 2008
Results First Submitted: November 4, 2011
Results First Posted: December 8, 2011
Last Update Posted: December 8, 2011