Tranexamic Acid Reduce Blood Loss in Meningioma Resection

Phase 4

• Conditions: Meningioma
• Interventions: Drug: Placebo; Drug: Tranexamic acid

• Registration Number: NCT04386642
• Lead Sponsor: Chiang Mai University

Brief Summary

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.

Detailed 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?

Study Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-13
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27
• Study Start: 2021-09-01
• Primary Completion: 2022-07-31
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	Normal saline solution 50 ml is prepared in a clear 50 ml syringe similar to the experiment group.
Experiment group	Tranexamic acid	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.

Primary Outcome Measures

Name	Time	Method
volume of intraoperative blood loss	in operating room during surgery	1. volume of blood presented in the suction bottle subtracted by the amount of water that the surgeon used in the surgical field; 2. the blood from the dry (30 ml) and wet swab (50 ml); 3. serial Hgb / Hct periodically during surgery and compare to those obtain before surgery

Secondary Outcome Measures

Name	Time	Method
volume of blood being transfused	during surgery and 24 hour after surgery	volume of pack red cell and other blood component (FFP, platelet)
surgeon rated for the satisfaction on hemostatic scale	in 2 hours after finish the operation	The surgeon will be informed about a Likert-type scale which is designed for clinical studies. The surgeon's satisfaction on hemostatic scale is a 3-graded scale modified from 5-graded validated bleeding severity scale. The original version is shown in the table 1. The surgeon will judge his satisfaction on hemostatic quality based on the most critical period or the overview of the surgical procedure. Even the long operative time, there will be one rate represent surgeon's opinion on hemostatic quality.
postoperative complications	in ICU neuro in 24 hours	bleeding, remarkable brain edema, re-craniotomy within 24 hours, worsening GCS, DIC, thromboembolic events, postoperative seizures
the duration of postoperative ventilator use	number of day remained intubation within 1 week after surgery	remain intubation
the length of neuro-ICU stays	number of day remained intubation within 1 week after surgery	how long the patient stay in ICU
the extent of tumor removal according to the surgeon decision	in 2 hours after finish the operation	completely or partially resection is rated by the surgeons

Trial Locations

Locations (1)

Chiang Mai University; 🇹🇭 Chiang Mai, Thailand