Efficacy of Tranexamic Acid in Brain Tumor Resections (COLFIRE)
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.
Drug: Tranexamic Acid
Drug: Placebo: Saline
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||PHASE 3 STUDY OF EFFICACY OF TRANEXAMIC ACID IN BRAIN TUMORS RESECTIONS|
- Number of patients with need of blood transfusion. [ Time Frame: 24-48 hours ] [ Designated as safety issue: Yes ](Measured with Hemoglobin/Hematocrit, PT, PTT, Plackets: pre-surgery, 6 hrs after surgery and 24 hours after.)
|Study Start Date:||July 2012|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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|
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.
|Contact: Randy Guerra, MD||575-6816577 ext email@example.com|
|Colombian foundation center for epilepsy and neurological disease||Recruiting|
|Cartagena, Bolivar, Colombia, 604|
|Contact: Randy Guerra, MD 575-6816577 ext 146 firstname.lastname@example.org|
|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|