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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01655927
Other study ID # NCT28072012FIRE
Secondary ID
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. completion date
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


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
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