Efficacy of Tranexamic Acid in Brain Tumor Resections (COLFIRE)

July 31, 2012 updated by: Colombian Foundation for Epilepsy and Neurological Disease

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Bolivar
      • Cartagena, Bolivar, Colombia, 604
        • Recruiting
        • Colombian foundation center for epilepsy and neurological disease
        • Contact:
        • Principal Investigator:
          • Fredy Diaz, MD
        • Sub-Investigator:
          • Randy Guerra, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with need of blood transfusion.
Time Frame: 24-48 hours
(Measured with Hemoglobin/Hematocrit, PT, PTT, Plackets: pre-surgery, 6 hrs after surgery and 24 hours after.)
24-48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colombian Foundation for Epilepsy and Neurological Disease

Investigators

  • Study Director: Randy O Guerra, MD, Colombian foundation center for epilepsy and neurological disease - FIRE
  • Principal Investigator: Fredy Diaz, MD, Colombian foundation center for epilepsy and neurological disease -FIRE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

July 30, 2012

First Submitted That Met QC Criteria

July 31, 2012

First Posted (Estimate)

August 2, 2012

Study Record Updates

Last Update Posted (Estimate)

August 2, 2012

Last Update Submitted That Met QC Criteria

July 31, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT28072012FIRE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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