Efficacy of Tranexamic Acid in Brain Tumor Resections

Neoplasms Clinical Trial

— COLFIRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01655927
• Other study ID #: NCT28072012FIRE
• Status: Recruiting
• Phase: Phase 3
• First received: July 30, 2012
• Last updated: July 31, 2012
• Start date: July 2012

Study information

• Verified date: July 2012
• Source: Colombian Foundation for Epilepsy and Neurological Disease
• Contact: Randy Guerra, MD
• Phone: 575-6816577
• Email: dr.randyguerra[@]gmail.com
• Is FDA regulated: No
• Health authority: Colombia:INVIMA
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astrocytoma
• Astrocytomas
• Brain Neoplasms
• Brain Tumors
• Gliomas
• Meningioma
• Meningiomas
• Neoplasms

Intervention

Drug:
• Tranexamic Acid

• Placebo: Saline

Locations

Country	Name	City	State
Colombia	Colombian foundation center for epilepsy and neurological disease	Cartagena	Bolivar

Sponsors (1)

Lead Sponsor	Collaborator
Colombian Foundation for Epilepsy and Neurological Disease

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

•   FIRE