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Efficacy of Tranexamic Acid in Brain Tumor Resections

PHASE 3 STUDY OF EFFICACY OF TRANEXAMIC ACID IN BRAIN TUMORS RESECTIONS

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01655927
Acronym
COLFIRE
Enrollment
100
Registered
2012-08-02
Start date
2012-07-31
Completion date
Unknown
Last updated
2012-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumors, Neoplasms, Gliomas, Astrocytomas, Meningiomas

Keywords

Neoplasms, Tranexamic Acid, Brain Tumors

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.

Interventions

DRUGTranexamic Acid

Sponsors

Colombian Foundation for Epilepsy and Neurological Disease
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with need of blood transfusion.24-48 hours(Measured with Hemoglobin/Hematocrit, PT, PTT, Plackets: pre-surgery, 6 hrs after surgery and 24 hours after.)

Countries

Colombia

Contacts

Primary ContactRandy Guerra, MD
dr.randyguerra@gmail.com575-6816577

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026