Efficacy of Tranexamic Acid in Brain Tumor Resections

Study Overview
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Brief Summary
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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
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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.

Official Title
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PHASE 3 STUDY OF EFFICACY OF TRANEXAMIC ACID IN BRAIN TUMORS RESECTIONS

Conditions
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Brain Tumors, Neoplasms, Gliomas, Astrocytomas, Meningiomas

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Placebo: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid<br>15 mg/Kg Tranexamic Acid IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory | Drug: Tranexamic Acid<br> <br> |
| Placebo Comparator: Saline (Placebo)<br>15 mg/Kg of Saline IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory | Drug: Placebo: Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasms, Tranexamic Acid, Brain Tumors