PHASE 3 STUDY OF EFFICACY OF TRANEXAMIC ACID IN BRAIN TUMORS RESECTIONS
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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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.)
Randy O Guerra, MD
Colombian foundation center for epilepsy and neurological disease - FIRE