Efficacy of Tranexamic Acid in Brain Tumor Resections (COLFIRE)
Primary Purpose
Brain Tumors, Neoplasms, Gliomas
Status
Unknown status
Phase
Phase 3
Locations
Colombia
Study Type
Interventional
Intervention
Tranexamic Acid
Placebo: Saline
Sponsored by
About this trial
This is an interventional treatment trial for Brain Tumors focused on measuring Neoplasms, Tranexamic Acid, Brain Tumors
Eligibility 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.
Sites / Locations
- Colombian foundation center for epilepsy and neurological diseaseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tranexamic Acid
Saline (Placebo)
Arm Description
15 mg/Kg Tranexamic Acid IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory
15 mg/Kg of Saline IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory
Outcomes
Primary Outcome Measures
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.)
Secondary Outcome Measures
Full Information
NCT ID
NCT01655927
First Posted
July 30, 2012
Last Updated
July 31, 2012
Sponsor
Colombian Foundation for Epilepsy and Neurological Disease
1. Study Identification
Unique Protocol Identification Number
NCT01655927
Brief Title
Efficacy of Tranexamic Acid in Brain Tumor Resections
Acronym
COLFIRE
Official Title
PHASE 3 STUDY OF EFFICACY OF TRANEXAMIC ACID IN BRAIN TUMORS RESECTIONS
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colombian Foundation for Epilepsy and Neurological Disease
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors, Neoplasms, Gliomas, Astrocytomas, Meningiomas
Keywords
Neoplasms, Tranexamic Acid, Brain Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic Acid
Arm Type
Experimental
Arm Description
15 mg/Kg Tranexamic Acid IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory
Arm Title
Saline (Placebo)
Arm Type
Placebo Comparator
Arm Description
15 mg/Kg of Saline IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Type
Drug
Intervention Name(s)
Placebo: Saline
Primary Outcome Measure Information:
Title
Number of patients with need of blood transfusion.
Description
(Measured with Hemoglobin/Hematocrit, PT, PTT, Plackets: pre-surgery, 6 hrs after surgery and 24 hours after.)
Time Frame
24-48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Randy Guerra, MD
Phone
575-6816577
Ext
146
Email
dr.randyguerra@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randy O Guerra, MD
Organizational Affiliation
Colombian foundation center for epilepsy and neurological disease - FIRE
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fredy Diaz, MD
Organizational Affiliation
Colombian foundation center for epilepsy and neurological disease -FIRE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colombian foundation center for epilepsy and neurological disease
City
Cartagena
State/Province
Bolivar
ZIP/Postal Code
604
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randy Guerra, MD
Phone
575-6816577
Ext
146
Email
dr.randyguerra@gmail.com
First Name & Middle Initial & Last Name & Degree
Fredy Diaz, MD
First Name & Middle Initial & Last Name & Degree
Randy Guerra, MD
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Tranexamic Acid in Brain Tumor Resections
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