Clinical trial NCT01655927: Efficacy of Tranexamic Acid in Brain Tumor Resections
Official title: PHASE 3 STUDY OF EFFICACY OF TRANEXAMIC ACID IN BRAIN TUMORS RESECTIONS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Brain Tumors
Neoplasms
Gliomas
Astrocytomas
Meningiomas
Keywords: Neoplasms
Tranexamic Acid
Brain Tumors
Lead sponsor: Colombian Foundation for Epilepsy and Neurological Disease
Sponsor class: OTHER
First posted: 2012-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Number of patients with need of blood transfusion.
timeFrame: 24-48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cartagena
country: Colombia
facility: Colombian foundation center for epilepsy and neurological disease
state: Bolivar
Study officials:
affiliation: Colombian foundation center for epilepsy and neurological disease - FIRE
name: Randy O Guerra, MD
role: STUDY_DIRECTOR
affiliation: Colombian foundation center for epilepsy and neurological disease -FIRE
name: Fredy Diaz, MD
role: PRINCIPAL_INVESTIGATOR
References: