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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-30

Study Completion Date

2024-07-11

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.

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Detailed Description

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Conditions

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Seizures Meningioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TXA group

The TXA group will receives Tranexamic acid intraoperative.

Group Type ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type DRUG

20mg/kg TXA was prepared in a 50ml syringe for intravenous pump

Placebo group

The TXA group will receives 0.9% saline intraoperative.

Group Type PLACEBO_COMPARATOR

0.9% saline

Intervention Type DRUG

0.9% saline was prepared in a 50ml syringe for intravenous pump

Interventions

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Tranexamic acid

20mg/kg TXA was prepared in a 50ml syringe for intravenous pump

Intervention Type DRUG

0.9% saline

0.9% saline was prepared in a 50ml syringe for intravenous pump

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No