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

Capital Medical University

Status: Completed

Conditions: Seizures; Meningioma

Treatments: Drug: Tranexamic acid; Drug: 0.9% saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04595786

ChiECRCT20200224

Details and patient eligibility

About

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.

Enrollment: 228 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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228 participants in 2 patient groups, including a placebo group

TXA group

Active Comparator group

Description:

The TXA group will receives Tranexamic acid intraoperative.

Treatment:

Drug: Tranexamic acid

Placebo group

Placebo Comparator group

Description:

The TXA group will receives 0.9% saline intraoperative.

Treatment:

Drug: 0.9% saline