Efficacy of Tranexamic Acid in Brain Tumor Resections (COLFIRE)
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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 |
- 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 |
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| Contact: Randy Guerra, MD | 575-6816577 ext 146 | dr.randyguerra@gmail.com |
| 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 | |
| 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:
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 May 22, 2013