The Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection

Seizures Clinical Trial

— STAMP  

Official title:

A Randomized, Parallel-group, Placebo Control, Non-inferiority Trial to Investigate the Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04595786
• Other study ID #: ChiECRCT20200224
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: February 24, 2023

Study information

• Verified date: January 2023
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Growing evidence of Tranexamic Acid (TXA) being used to reduce blood loss and blood transfusions in various guidelines. However, the adverse effects of TXA especially seizure has always been a problem of concern, especially in neurosurgery. Therefore, this study aims to provide a scientific evidence for the safety of TXA in supratentorial meningiomas resection patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: February 24, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 1) age 18-80 years
• 2) American Society of Anesthesiologist (ASA) classification score I~III

Exclusion Criteria:

• 1) allergic to tranexamic acid
• 2) preoperative seizures
• 3) history of thrombotic disease
• 4) chronic kidney disease
• 5) breastfeeding or pregnancy
• 6) refuse to participate in the study

Related Conditions & MeSH terms

• Meningioma
• Seizures

Intervention

Drug:
• Tranexamic acid
20mg/kg TXA was prepared in a 50ml syringe for intravenous pump
• 0.9% saline
0.9% saline was prepared in a 50ml syringe for intravenous pump

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	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	Early postoperative seizures within 7 days	Postoperative seizures were defined as a transient occurrence of involuntary movements, abnormal sensory phenomena, or an altered mental status that could not otherwise be explained.	Within 7 days after surgery
Secondary	The incidence of non-epileptic complications	Including intracranial hematoma, deep vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, stroke, myocardial infarction, acute kidney infarction, anaemia, and infection.	Within 7 days after the intervention
Secondary	Estimated intraoperative blood loss	Estimated intraoperative blood loss = collected blood volume in the suction canister (ml) - volume of flushing (ml) + volume from gauze tampon (ml).	During surgery
Secondary	The changes in haemoglobin concentrations	The changes in haemoglobin concentrations between baseline and end of surgery.	During surgery
Secondary	The intraoperative blood transfusion volume and rate	The intraoperative blood transfusion volume and rate.	During surgery
Secondary	The intraoperative cell saver volume and rate	The intraoperative cell saver volume and rate.	During surgery