Efficacy of Tranexamic Acid in Brain Tumor Resections (COLFIRE)
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|ClinicalTrials.gov Identifier: NCT01655927|
Recruitment Status : Unknown
Verified July 2012 by Colombian Foundation for Epilepsy and Neurological Disease.
Recruitment status was: Recruiting
First Posted : August 2, 2012
Last Update Posted : August 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumors Neoplasms Gliomas Astrocytomas Meningiomas||Drug: Tranexamic Acid Drug: Placebo: Saline||Phase 3|
Brain tumor resection has been associated with increased blood loss and a significant increase in the incidence of Intravascular disseminated coagulopathy. The development of coagulopathy in the context of tumor resection is associated with poor results. Transfusion decision during the course of neurosurgical surgery offers benefits such as increased oxygen carrying capacity but may increase the risk associated with transfusions such as blood infections, hemolysis, lung injury and immunosuppression. The information available on tranexamic acid used in neurosurgery is little, therefore this opens up new alternatives in the techniques of reducing intraoperative bleeding.
Tranexamic acid is an antifibrinolytic agent that blocks the binding of plasminogen to the fibrin surface. It has been used to reduce blood loss during coronary revascularization, liver resection, obstetrics and orthopedic procedures. Tranexamic acid intraoperatively has been shown to reduce blood loss up to 45%. The primary concern when administering an antifibrinolytic drug is the potential increased incidence of thromboembolic events. There is no actual data on the utility of tranexamic acid to reduce blood loss in brain tumors resection surgery.
We want to compare Tranexamic Acid to Saline solution(Placebo) to see whether Tranexamic ACid Administration will reduce blood loss during brain tumor resection. Reduction in transfusion requirements will lead to reduced costs and possible reduction in complications of blood transfusion and perioperative incidents.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||PHASE 3 STUDY OF EFFICACY OF TRANEXAMIC ACID IN BRAIN TUMORS RESECTIONS|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||July 2013|
Experimental: Tranexamic Acid
15 mg/Kg Tranexamic Acid IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory
Drug: Tranexamic Acid
Placebo Comparator: Saline (Placebo)
15 mg/Kg of Saline IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory
Drug: Placebo: Saline
- Number of patients with need of blood transfusion. [ Time Frame: 24-48 hours ](Measured with Hemoglobin/Hematocrit, PT, PTT, Plackets: pre-surgery, 6 hrs after surgery and 24 hours after.)
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): NCT01655927
|Contact: Randy Guerra, MD||575-6816577 ext firstname.lastname@example.org|
|Colombian foundation center for epilepsy and neurological disease||Recruiting|
|Cartagena, Bolivar, Colombia, 604|
|Contact: Randy Guerra, MD 575-6816577 ext 146 email@example.com|
|Principal Investigator: Fredy Diaz, MD|
|Sub-Investigator: Randy Guerra, MD|
|Study Director:||Randy O Guerra, MD||Colombian foundation center for epilepsy and neurological disease - FIRE|
|Principal Investigator:||Fredy Diaz, MD||Colombian foundation center for epilepsy and neurological disease -FIRE|