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

Effects of Tranexamic Acid on mortality and transfusion rate in children undergoing Central Nervous System Tumor Resection Surgery: randomized, double-blind, placebo-controlled clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-863mw5z
Enrollment
Unknown
Registered
2023-05-04
Start date
2023-04-24
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Neoplasms of the Central Nervous System

Interventions

For the intervention group, after anesthesia and before the beginning of the operative time, the patients will receive an initial dose of 15mg/kg of tranexamic acid, diluted in saline solution (0.9%)

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Grupo de Apoio ao Adolescente e à Criança com Câncer
Collaborator

Eligibility

Age
No minimum to 18 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Brazil

Contacts

Public ContactMarcos Devanir da Costa

Grupo de Apoio ao Adolescente e à Criança com Câncer

marcoscostaneuro@gmail.com+55(11) 5080-8400

Outcome results

None listed

Source: REBEC (via WHO ICTRP)