Efficacy of Tranexamic Acid in Brain Tumor Resections (COLFIRE)

Colombian Foundation for Epilepsy and Neurological Disease

Status and phase: Unknown; Phase 3

Conditions: Neoplasms; Brain Tumors; Gliomas; Astrocytomas; Meningiomas

Treatments: Drug: Placebo: Saline; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01655927

NCT28072012FIRE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Tranexamic Acid

Experimental group

Description:

15 mg/Kg Tranexamic Acid IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory

Treatment:

Drug: Tranexamic Acid

Saline (Placebo)

Placebo Comparator group

Description:

15 mg/Kg of Saline IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory

Treatment:

Drug: Placebo: Saline