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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05230381
Other study ID # 2022018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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