Efficacy of Tranexamic Acid in Brain Tumor Resections

NCT01655927 | Unknown Phase 3 DMC

• 1 other identifier: NCT28072012FIRE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumors; Neoplasms; Gliomas; Astrocytomas; Meningiomas

Keywords

Neoplasms; Tranexamic Acid; Brain Tumors

Outcome Measures

Primary Outcomes (1)

• 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.)

  24-48 hours

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

15 mg/Kg Tranexamic Acid IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory

Drug: Tranexamic Acid

Saline (Placebo)

PLACEBO COMPARATOR

15 mg/Kg of Saline IV after anesthesic induction,and continues with a dose of 1mg/kg/h intraoperatory

Drug: Placebo: Saline

Interventions

Tranexamic Acid DRUG

Tranexamic Acid

Placebo: Saline DRUG

Saline (Placebo)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who agree to participate by giving informed consent
• Eligible previously untreated patients with resectable brain tumor.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colombian Foundation for Epilepsy and Neurological Disease: lead

Study Sites (1)

Colombian foundation center for epilepsy and neurological disease

Cartagena, Departamento de Bolívar, 604, Colombia

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Neoplasms; Glioma; Astrocytoma; Meningioma

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Randy O Guerra, MD

  Colombian foundation center for epilepsy and neurological disease - FIRE

  STUDY DIRECTOR

• Fredy Diaz, MD

  Colombian foundation center for epilepsy and neurological disease -FIRE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Randy Guerra, MD

CONTACT

575-6816577; dr.randyguerra@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 2, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Last Updated: August 2, 2012

Record last verified: 2012-07

Locations

CO (1)