Study on the effects of Tranexamic Acid on death and the need for blood during surgery in children operated on for Brain Tumors

Phase 3

Recruiting

• Conditions: eoplasms of the Central Nervous System; Surgical Bleeding; C23.550.505

• Registration Number: RBR-863mw5z
• Lead Sponsor: niversidade Federal de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-04
• Last Update Posted: 29 May 2023
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients from both genders; younger than 18 years old with a diagnosis of central nervous system tumor, characterized by radiological imaging (tomography or magnetic resonance imaging); whether it's their first surgery or reoperation due to relapse or progression; preoperative hemoglobin greater than 10mg/dl

Exclusion Criteria

Patients over 18 years of age; patients with tumors in sites other than the intracranial compartment; patients with a history of hematological, liver, kidney, vascular diseases or who have had a previous thromboembolic event; patients who refuse to participate voluntarily will be excluded from the study; patients with epilepsy refractory to anticonvulsant medication (defined as the presence of seizures in a period of less than 12 months in patients with at least two anticonvulsants in an optimized dose); patients with tumors with a volume greater than 50% of a cerebral hemisphere

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expect to find in this study the reduction of mortality and perioperative transfusion through the use of tranexamic acid in surgery of children with tumors of the central nervous system

Secondary Outcome Measures

Name	Time	Method
Expect to find a reduction in intraoperative bleeding with the use of tranexamic acid in children undergoing resection of central nervous system tumors.;Expect to find a reduction in the use of intraoperative vasoactive drugs with the use of tranexamic acid in children undergoing resection of central nervous system tumors;We will observe the safety of the use of tranexamic acid through the surveillance of events such as seizures and thromboembolism in the first 7 postoperative days or until hospital discharge