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

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

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.

Study Overview

• Status: Completed
• Conditions: Seizures; Meningioma
• Intervention / Treatment: Drug: Tranexamic acid; Drug: 0.9% saline

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TXA group; The TXA group will receives Tranexamic acid intraoperative.	Drug: Tranexamic acid; 20mg/kg TXA was prepared in a 50ml syringe for intravenous pump
Placebo Comparator: Placebo group; The TXA group will receives 0.9% saline intraoperative.	Drug: 0.9% saline; 0.9% saline was prepared in a 50ml syringe for intravenous pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
The changes in haemoglobin concentrations	The changes in haemoglobin concentrations between baseline and end of surgery.	During surgery
The intraoperative blood transfusion volume and rate	The intraoperative blood transfusion volume and rate.	During surgery
The intraoperative cell saver volume and rate	The intraoperative cell saver volume and rate.	During surgery

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Yuming Peng, M.D., Ph.D, Beijing Tiantan Hospital

Publications and helpful links

General Publications

• Li S, Yan X, Li R, Zhang X, Ma T, Zeng M, Dong J, Wang J, Liu X, Peng Y. Safety of intravenous tranexamic acid in patients undergoing supratentorial meningiomas resection: protocol for a randomised, parallel-group, placebo control, non-inferiority trial. BMJ Open. 2022 Feb 2;12(2):e052095. doi: 10.1136/bmjopen-2021-052095.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Actual): January 11, 2024
• Study Completion (Actual): July 11, 2024

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: meningioma; blood management
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Meningioma; Seizures; Molecular Mechanisms of Pharmacological Action; Antifibrinolytic Agents; Fibrin Modulating Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: ChiECRCT20200224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual, de-identified participant data will be shared two years after the publication of primary outcome data, by request from any qualified investigator following approval of a protocol, statistical analysis plan, and receipt of a signed data access agreement via the research office and the Beijing Tiantan Hospital Ethics Committees for the project and data release.
• IPD Sharing Time Frame: Two years after the primary outcome data is published.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No