Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection

Meningioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05230381
• Other study ID #: 2022018
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2022
• Source: Beijing Tiantan Hospital
• Contact: Shu Li, M.D.
• Phone: 8613699223065
• Email: lishu[@]bjtth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ? to ?
• 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

Related Conditions & MeSH terms

• Hemorrhage
• Intraoperative Blood Loss
• Meningioma
• Tranexamic Acid

Intervention

Drug:
• Continous infusion
The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by 5mg/kg/h tranexamic acid infusion.
• Single infusion
The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by same volume of 0.9% saline.
• Placebo
The 0.9% saline is administered with the same volume at the same speed as the other group.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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