Efficacy of Tranexamic Acid in Brain Tumor Resections
Conditions
Brain Tumors - Neoplasms - Gliomas - Astrocytomas - Meningiomas
Conditions: official terms
Brain Neoplasms - Meningioma
Conditions: Keywords
Neoplasms, Tranexamic Acid, Brain Tumors
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Tranexamic Acid Type: Drug
Name: Placebo: Saline Type: Drug
Overall Status
Recruiting
Summary
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
Colombian foundation center for epilepsy and neurological disease
Cartagena, Bolivar, Colombia
Status: Recruiting
Contact: Randy Guerra, MD - 575-6816577 - dr.randyguerra@gmail.com
Start Date
July 2012
Sponsors
Colombian Foundation for Epilepsy and Neurological Disease
Source
Colombian Foundation for Epilepsy and Neurological Disease
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page