Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection

Not Applicable

Recruiting

• Conditions: Tranexamic Acid; Meningioma; Intraoperative Blood Loss
• Interventions: Drug: Continous infusion; Drug: Single infusion; Drug: Placebo

• Registration Number: NCT05230381
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-02-06
• Study First Posted: 2022-02-08
• Study Start: 2022-06-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-29
• Primary Completion: 2024-12-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continous infusion group	Continous infusion	Infusion with 20mg/kg tranexamic acid and 5mg/kg/h tranexamic acid.
Single infusion group	Single infusion	Infusion with 20mg/kg tranexamic acid and same volume 0.9% saline.
Placebo group	Placebo	Infusion with same volume of 0.9% saline.

Primary Outcome Measures

Name	Time	Method
Estimated intra-operative blood loss	During surgery	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).

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China