Tranexamic Acid Reduce Blood Loss in Meningioma 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

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-09-30

Brief Summary

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In neurosurgical setting, a large sample size trials of tranexamic acid (TXA) has been limited to TBI and SAH.

The evidence of TXA in brain tumor was scarce. A few case reports support the role of TXA in brain tumor patients with significant intraoperative bleeding and difficult achieving hemostasis. To prove the benefit of TXA for an attenuation of blood loss in brain tumor patients, research with a larger sample size is required. This prospective, randomized double-blind controlled study will be conducted to evaluate the effect of TXA in reducing blood loss and blood transfusion in patients with intracranial meningiomas, diameter \> 5 cm in at least 2 dimensions from the latest radiographic findings.

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Detailed Description

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Background and Literature review:

1. Meningioma
2. Coagulation in craniotomy to remove meningioma
3. Bleeding in craniotomy to remove meningioma
4. Tranexamic acid (TXA)
5. Knowledge gap The topics shown above has been reviewed to conduct a prospective randomized double-blind, placebo controlled study.

To prove the study hypothesis: Will intraoperative TXA administration in adult patients scheduled for craniotomy to remove large meningioma decrease blood loss?

Conditions

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Meningioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients will be randomized into two parallel groups by block of four randomization.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The patients and outcome assessors are blinded to the drug that will be prepared by a pharmacist in the similar unlabelled 50-ml syringe.

Study Groups

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Experiment group

Each ampule contains TXA 250 mg. TXA preparation is 2000 mg dilute in normal saline 50 ml to get the concentration of 40 mg/ml. TXA will be administered 20 mg/kg loading over 20 min before skin incision followed by a maintenance infusion of 0.025 ml/kg/h (1 mg/kg/h) until the end of operation.

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

Tranexamic acid 2000 mg dilute in normal saline solution 50 ml.

Control group

Normal saline solution 50 ml is prepared in a clear 50 ml syringe similar to the experiment group.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

normal saline solution in a clear 50-ml syringe

Interventions

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Tranexamic acid

Tranexamic acid 2000 mg dilute in normal saline solution 50 ml.

Intervention Type DRUG

Placebo

normal saline solution in a clear 50-ml syringe

Intervention Type DRUG

Other Intervention Names

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group T group N

Eligibility Criteria

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Inclusion Criteria

* The patients whose aged 18 to 60 years
* The patients who was diagnosed intracranial meningioma
* The radio-graphic finding of tumor diameter \> 5 cm in at least 2 dimensions
* The patients have written informed consent
* The patients is scheduled for elective craniotomy to remove tumor

Exclusion Criteria

* Patients who refuse to participate in this study
* Patients with recurrent tumor
* The patient is set operation for intracranial tissue biopsy
* The patients with history of TXA allergy
* The pregnant patients
* The patients with history of significant thromboembolic episode
* The patients with significant renal dysfunction (GFR ≤ 50 ml/min)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No