The Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection

Not Applicable

Completed

• Conditions: Meningioma; Seizures
• Interventions: Drug: 0.9% saline; Drug: Tranexamic acid

• Registration Number: NCT04595786
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

Growing evidence of Tranexamic Acid (TXA) being used to reduce blood loss and blood transfusions in various guidelines. However, the adverse effects of TXA especially seizure has always been a problem of concern, especially in neurosurgery. Therefore, this study aims to provide a scientific evidence for the safety of TXA in supratentorial meningiomas resection patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2020-10-14
• Study First Posted: 2020-10-22
• Study Start: 2020-10-30
• Primary Completion: 2024-01-11
• Study Completion: 2024-07-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-02
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

• 1. age 18-80 years
• 2. American Society of Anesthesiologist (ASA) classification score I~III

Exclusion Criteria

• 1. allergic to tranexamic acid
• 2. preoperative seizures
• 3. history of thrombotic disease
• 4. chronic kidney disease
• 5. breastfeeding or pregnancy
• 6. refuse to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	0.9% saline	The TXA group will receives 0.9% saline intraoperative.
TXA group	Tranexamic acid	The TXA group will receives Tranexamic acid intraoperative.

Primary Outcome Measures

Name	Time	Method
Early postoperative seizures within 7 days	Within 7 days after surgery	Postoperative seizures were defined as a transient occurrence of involuntary movements, abnormal sensory phenomena, or an altered mental status that could not otherwise be explained.

Secondary Outcome Measures

Name	Time	Method
The intraoperative blood transfusion volume and rate	During surgery	The intraoperative blood transfusion volume and rate.
The incidence of non-epileptic complications	Within 7 days after the intervention	Including intracranial hematoma, deep vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, stroke, myocardial infarction, acute kidney infarction, anaemia, and infection.
Estimated intraoperative blood loss	During surgery	Estimated intraoperative blood loss = collected blood volume in the suction canister (ml) - volume of flushing (ml) + volume from gauze tampon (ml).
The intraoperative cell saver volume and rate	During surgery	The intraoperative cell saver volume and rate.
The changes in haemoglobin concentrations	During surgery	The changes in haemoglobin concentrations between baseline and end of surgery.

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China