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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04595786
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing Tiantan Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yuming Peng, M.D., Ph.D
Principal Investigator Affiliation	Beijing Tiantan Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Seizures, Meningioma

Arms & Interventions

Arms

Active Comparator: TXA group

The TXA group will receives Tranexamic acid intraoperative.

Placebo Comparator: Placebo group

The TXA group will receives 0.9% saline intraoperative.

Interventions

Drug: - Tranexamic acid

20mg/kg TXA was prepared in a 50ml syringe for intravenous pump

Drug: - 0.9% saline

0.9% saline was prepared in a 50ml syringe for intravenous pump

Contact a Trial Team

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