Neoplasms Clinical Trial
— COLFIREOfficial title:
PHASE 3 STUDY OF EFFICACY OF TRANEXAMIC ACID IN BRAIN TUMORS RESECTIONS
NCT number | NCT01655927 |
Other study ID # | NCT28072012FIRE |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | July 30, 2012 |
Last updated | July 31, 2012 |
Start date | July 2012 |
The purpose of this study is to determine whether Tranexamic Acid is effective or not in the reduction of intraoperative bleeding loss in brain tumors resections.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients who agree to participate by giving informed consent - Eligible previously untreated patients with resectable brain tumor. Exclusion Criteria: - Patients with previous thromboembolic events. - Patients with coagulopathy or anticoagulation therapy. (Abnormal PT, PTT) - Patients with impaired renal function (Creatinine >1.1mg/dl) - Patients with known contraindications to fibrinolytic treatment. - Patients receiving rejection therapy. - Patients with abnormal liver function. - Known allergies to Tranexamic Acid. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Colombia | Colombian foundation center for epilepsy and neurological disease | Cartagena | Bolivar |
Lead Sponsor | Collaborator |
---|---|
Colombian Foundation for Epilepsy and Neurological Disease |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with need of blood transfusion. | (Measured with Hemoglobin/Hematocrit, PT, PTT, Plackets: pre-surgery, 6 hrs after surgery and 24 hours after.) | 24-48 hours | Yes |
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