Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge 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

UNKNOWN

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-15

Study Completion Date

2025-06-30

Brief Summary

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Intra-operative blood loss of huge meningioma resection patients on average was over 1000ml. Intra-operative massive hemorrhage was associated with longer hospital of stay, higher expense, and higher mortality. Previous studies indicated intra-operative tranexamic acid infusion would decrease blood loss for cardiac, trauma and obstetric procedures. However, limited researches focusing on the effect of tranexamic acid in neurosurgery population, with heterogenous pathologies. The purpose of this study was to investigate the effect of tranexamic acid on intra-operative blood loss in patients undergoing huge meningioma resection.

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Detailed Description

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Conditions

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Tranexamic Acid Intraoperative Blood Loss Meningioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Continous infusion group

Infusion with 20mg/kg tranexamic acid and 5mg/kg/h tranexamic acid.

Group Type ACTIVE_COMPARATOR

Continous infusion

Intervention Type DRUG

The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by 5mg/kg/h tranexamic acid infusion.

Single infusion group

Infusion with 20mg/kg tranexamic acid and same volume 0.9% saline.

Group Type ACTIVE_COMPARATOR

Single infusion

Intervention Type DRUG

The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by same volume of 0.9% saline.

Placebo group

Infusion with same volume of 0.9% saline.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The 0.9% saline is administered with the same volume at the same speed as the other group.

Interventions

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Continous infusion

The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by 5mg/kg/h tranexamic acid infusion.

Intervention Type DRUG

Single infusion

The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by same volume of 0.9% saline.

Intervention Type DRUG

Placebo

The 0.9% saline is administered with the same volume at the same speed as the other group.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing elective supratentorial meningioma resection with estimated tumor diameter \>5cm on brain image.
* Age between 18-65 years.
* American Society of Anaesthesiologist (ASA) physical status Ⅰ to Ⅲ
* Obtain written informed consent.

Exclusion Criteria

* Allergic to tranexamic acid.
* History of thrombotic disease.
* History of chronic kidney disease
* Receiving other anticoagulation or antiplatelet treatment.
* Refuse to provide written informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No