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

July 30, 2012
July 31, 2012
July 2012
July 2013   (final data collection date for primary outcome measure)
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.)
Same as current
Complete list of historical versions of study NCT01655927 on ClinicalTrials.gov Archive Site
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Not Provided
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Efficacy of Tranexamic Acid in Brain Tumor Resections
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Brain Tumors
  • Neoplasms
  • Gliomas
  • Astrocytomas
  • Meningiomas
  • Drug: Tranexamic Acid
  • Drug: Placebo: Saline
  • Experimental: Tranexamic Acid
    15 mg/Kg Tranexamic Acid IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory
    Intervention: 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
    Intervention: Drug: Placebo: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Randy Guerra, MD 575-6816577 ext 146 dr.randyguerra@gmail.com
Colombia
 
NCT01655927
NCT28072012FIRE
Yes
Colombian Foundation for Epilepsy and Neurological Disease
Colombian Foundation for Epilepsy and Neurological Disease
Not Provided
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
Colombian Foundation for Epilepsy and Neurological Disease
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP