NCT04595786

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2024

Completed
Last Updated

March 4, 2025

Status Verified

March 1, 2025

Enrollment Period

3.2 years

First QC Date

October 9, 2020

Last Update Submit

March 2, 2025

Conditions

SeizuresMeningioma

Keywords

meningiomablood management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • The incidence of non-epileptic complications

    Within 7 days after the intervention

  • Estimated intraoperative blood loss

    During surgery

  • The changes in haemoglobin concentrations

    During surgery

  • The intraoperative blood transfusion volume and rate

    During surgery

  • The intraoperative cell saver volume and rate

    During surgery

Study Arms (2)

TXA group

ACTIVE COMPARATOR

The TXA group will receives Tranexamic acid intraoperative.

Drug: Tranexamic acid

Placebo group

PLACEBO COMPARATOR

The TXA group will receives 0.9% saline intraoperative.

Drug: 0.9% saline

Interventions

Tranexamic acidDRUG

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

TXA group
0.9% salineDRUG

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

Placebo group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \) allergic to tranexamic acid
  • \) preoperative seizures
  • \) history of thrombotic disease
  • \) chronic kidney disease
  • \) breastfeeding or pregnancy
  • \) refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (2)

  • Li S, Liu M, Yang J, Yan X, Wu Y, Zhang L, Zeng M, Zhou D, Peng Y, Sessler DI. Intravenous tranexamic acid for intracerebral meningioma resections: A randomized, parallel-group, non-inferiority trial. J Clin Anesth. 2024 Feb;92:111285. doi: 10.1016/j.jclinane.2023.111285. Epub 2023 Oct 17.

    PMID: 37857168DERIVED

  • 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.

    PMID: 35110315DERIVED

MeSH Terms

Conditions

SeizuresMeningioma

Interventions

Tranexamic AcidSaline Solution

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Yuming Peng, M.D., Ph.D

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy chief of Department of Anesthesiology

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 22, 2020

Study Start

October 30, 2020

Primary Completion

January 11, 2024

Study Completion

July 11, 2024

Last Updated

March 4, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Two years after the primary outcome data is published.

Locations

CN(1)