Tranexamic Acid Reduce Blood Loss in Meningioma Resection

Study Overview
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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.

Detailed Description
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Background and Literature review: Meningioma Coagulation in craniotomy to remove meningioma Bleeding in craniotomy to remove meningioma Tranexamic acid (TXA) 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?

Official Title
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Effect of Tranexamic Acid Infusion to Reduce Intraoperative Blood Loss in Large Meningioma: A Prospective Randomized Double-blind Control Study

Conditions
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Meningioma

Intervention / Treatment
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* Drug: Tranexamic acid
* Drug: Placebo


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be randomized into two parallel groups by block of four randomization.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experiment group<br>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. | Drug: Tranexamic acid<br>* Tranexamic acid 2000 mg dilute in normal saline solution 50 ml.<br>* Other names: group T;|
| Placebo Comparator: Control group<br>Normal saline solution 50 ml is prepared in a clear 50 ml syringe similar to the experiment group. | Drug: Placebo<br>* normal saline solution in a clear 50-ml syringe<br>* Other names: group N;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume of intraoperative blood loss | volume of blood presented in the suction bottle subtracted by the amount of water that the surgeon used in the surgical field the blood from the dry (30 ml) and wet swab (50 ml) serial Hgb / Hct periodically during surgery and compare to those obtain before surgery | in operating room during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume of blood being transfused | volume of pack red cell and other blood component (FFP, platelet) | during surgery and 24 hour after surgery | 
| surgeon rated for the satisfaction on hemostatic scale | 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. | in 2 hours after finish the operation | 
| the extent of tumor removal according to the surgeon decision | completely or partially resection is rated by the surgeons | in 2 hours after finish the operation | 
| postoperative complications | bleeding, remarkable brain edema, re-craniotomy within 24 hours, worsening GCS, DIC, thromboembolic events, postoperative seizures | in ICU neuro in 24 hours | 
| the duration of postoperative ventilator use | remain intubation | number of day remained intubation within 1 week after surgery | 
| the length of neuro-ICU stays | how long the patient stay in ICU | number of day remained intubation within 1 week after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tranexamic acid, Meningioma, Blood loss