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Efficacy of Tranexamic Acid in Brain Tumor Resections

NCT ID: NCT01655927

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Brain Tumors Neoplasms Gliomas Astrocytomas Meningiomas

Keywords

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Neoplasms Tranexamic Acid Brain Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Tranexamic Acid

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

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Saline (Placebo)

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

Group Type PLACEBO_COMPARATOR

Placebo: Saline

Intervention Type DRUG

Interventions

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Tranexamic Acid

Intervention Type DRUG

Placebo: Saline

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Colombian Foundation for Epilepsy and Neurological Disease

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Randy O Guerra, MD

Role: STUDY_DIRECTOR

Colombian foundation center for epilepsy and neurological disease - FIRE

Fredy Diaz, MD

Role: PRINCIPAL_INVESTIGATOR

Colombian foundation center for epilepsy and neurological disease -FIRE

Locations

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Colombian foundation center for epilepsy and neurological disease

Cartagena, Departamento de Bolívar, Colombia

Site Status RECRUITING

Countries

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Colombia

Central Contacts

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Randy Guerra, MD

Role: CONTACT

Phone: 575-6816577

Email: [email protected]

Facility Contacts

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Randy Guerra, MD

Role: primary

Other Identifiers

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NCT28072012FIRE

Identifier Type: -

Identifier Source: org_study_id