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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Parallel-group, Placebo Control, Non-inferiority Trial to Investigate the Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection

Conditions
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Seizures, Meningioma

Intervention / Treatment
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* Drug: Tranexamic acid
* Drug: 0.9% saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TXA group<br>The TXA group will receives Tranexamic acid intraoperative. | Drug: Tranexamic acid<br>* 20mg/kg TXA was prepared in a 50ml syringe for intravenous pump<br>|
| Placebo Comparator: Placebo group<br>The TXA group will receives 0.9% saline intraoperative. | Drug: 0.9% saline<br>* 0.9% saline was prepared in a 50ml syringe for intravenous pump<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early postoperative seizures within 7 days | 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. | Within 7 days after surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meningioma, blood management