Tranexamic Acid Reduce Blood Loss in Meningioma Resection

Chiang Mai University

Status and phase: Unknown; Phase 4

Conditions: Meningioma

Treatments: Drug: Tranexamic acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04386642

ANE_07052020

Details and patient eligibility

About

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.

Full description

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?

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Experiment group

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic acid

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo