Efficacy of Tranexamic Acid in Brain Tumor Resections (COLFIRE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Colombian Foundation for Epilepsy and Neurological Disease.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Colombian Foundation for Epilepsy and Neurological Disease
ClinicalTrials.gov Identifier:
NCT01655927
First received: July 30, 2012
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Brain Tumors
Neoplasms
Gliomas
Astrocytomas
Meningiomas
Drug: Tranexamic Acid
Drug: Placebo: Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PHASE 3 STUDY OF EFFICACY OF TRANEXAMIC ACID IN BRAIN TUMORS RESECTIONS

Resource links provided by NLM:


Further study details as provided by Colombian Foundation for Epilepsy and Neurological Disease:

Primary Outcome Measures:
  • Number of patients with need of blood transfusion. [ Time Frame: 24-48 hours ] [ Designated as safety issue: Yes ]
    (Measured with Hemoglobin/Hematocrit, PT, PTT, Plackets: pre-surgery, 6 hrs after surgery and 24 hours after.)


Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655927

Contacts
Contact: Randy Guerra, MD 575-6816577 ext 146 dr.randyguerra@gmail.com

Locations
Colombia
Colombian foundation center for epilepsy and neurological disease Recruiting
Cartagena, Bolivar, Colombia, 604
Contact: Randy Guerra, MD    575-6816577 ext 146    dr.randyguerra@gmail.com   
Principal Investigator: Fredy Diaz, MD         
Sub-Investigator: Randy Guerra, MD         
Sponsors and Collaborators
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
  More Information

Additional Information:
FIRE  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Colombian Foundation for Epilepsy and Neurological Disease
ClinicalTrials.gov Identifier: NCT01655927     History of Changes
Other Study ID Numbers: NCT28072012FIRE
Study First Received: July 30, 2012
Last Updated: July 31, 2012
Health Authority: Colombia:INVIMA

Keywords provided by Colombian Foundation for Epilepsy and Neurological Disease:
Neoplasms
Tranexamic Acid
Brain Tumors

Additional relevant MeSH terms:
Meningioma
Astrocytoma
Brain Neoplasms
Neoplasms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014