Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection

Study Overview
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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.

Official Title
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Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Brain Meningioma Resections: Study Protocol of a Randomised Controlled Trial

Conditions
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Tranexamic Acid, Intraoperative Blood Loss, Meningioma

Intervention / Treatment
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* Drug: Continous infusion
* Drug: Single infusion
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continous infusion group<br>Infusion with 20mg/kg tranexamic acid and 5mg/kg/h tranexamic acid. | Drug: Continous infusion<br>* The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by 5mg/kg/h tranexamic acid infusion.<br>|
| Active Comparator: Single infusion group<br>Infusion with 20mg/kg tranexamic acid and same volume 0.9% saline. | Drug: Single infusion<br>* The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by same volume of 0.9% saline.<br>|
| Placebo Comparator: Placebo group<br>Infusion with same volume of 0.9% saline. | Drug: Placebo<br>* The 0.9% saline is administered with the same volume at the same speed as the other group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated intra-operative blood loss | Estimated intra-operative blood loss is assessed as following formula:collected blood volume in the suction canister (mL) - the volume of flushing (mL) + the volume from gauze tampon (mL). | During surgery |