- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01655927
Efficacy of Tranexamic Acid in Brain Tumor Resections (COLFIRE)
PHASE 3 STUDY OF EFFICACY OF TRANEXAMIC ACID IN BRAIN TUMORS RESECTIONS
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Randy Guerra, MD
- Phone Number: 146 575-6816577
- Email: dr.randyguerra@gmail.com
Study Locations
-
-
Bolivar
-
Cartagena, Bolivar, Colombia, 604
- Recruiting
- Colombian foundation center for epilepsy and neurological disease
-
Contact:
- Randy Guerra, MD
- Phone Number: 146 575-6816577
- Email: dr.randyguerra@gmail.com
-
Principal Investigator:
- Fredy Diaz, MD
-
Sub-Investigator:
- Randy Guerra, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tranexamic Acid
15 mg/Kg Tranexamic Acid IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory
|
|
Placebo Comparator: Saline (Placebo)
15 mg/Kg of Saline IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with need of blood transfusion.
Time Frame: 24-48 hours
|
(Measured with Hemoglobin/Hematocrit, PT, PTT, Plackets: pre-surgery, 6 hrs after surgery and 24 hours after.)
|
24-48 hours
|
Collaborators and Investigators
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Neoplasms, Vascular Tissue
- Meningeal Neoplasms
- Brain Neoplasms
- Astrocytoma
- Meningioma
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Tranexamic Acid
Other Study ID Numbers
- NCT28072012FIRE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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