NCT05230381

Brief Summary

Intra-operative blood loss of huge meningioma resection patients on average was over 1000ml. Intra-operative massive hemorrhage was associated with longer hospital of stay, higher expense, and higher mortality. Previous studies indicated intra-operative tranexamic acid infusion would decrease blood loss for cardiac, trauma and obstetric procedures. However, limited researches focusing on the effect of tranexamic acid in neurosurgery population, with heterogenous pathologies. The purpose of this study was to investigate the effect of tranexamic acid on intra-operative blood loss in patients undergoing huge meningioma resection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 5, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

2.5 years

First QC Date

January 5, 2022

Last Update Submit

August 24, 2022

Conditions

Tranexamic AcidIntraoperative Blood LossMeningioma

Outcome Measures

Primary Outcomes (1)

  • Estimated intra-operative blood loss

    Estimated intra-operative blood loss is assessed as following formula:collected blood volume in the suction canister (mL) - the volume of flushing (mL) + the volume from gauze tampon (mL).

    During surgery

Study Arms (3)

Continous infusion group

ACTIVE COMPARATOR

Infusion with 20mg/kg tranexamic acid and 5mg/kg/h tranexamic acid.

Drug: Continous infusion

Single infusion group

ACTIVE COMPARATOR

Infusion with 20mg/kg tranexamic acid and same volume 0.9% saline.

Drug: Single infusion

Placebo group

PLACEBO COMPARATOR

Infusion with same volume of 0.9% saline.

Drug: Placebo

Interventions

Continous infusionDRUG

The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by 5mg/kg/h tranexamic acid infusion.

Continous infusion group
Single infusionDRUG

The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by same volume of 0.9% saline.

Single infusion group
PlaceboDRUG

The 0.9% saline is administered with the same volume at the same speed as the other group.

Placebo group

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing elective supratentorial meningioma resection with estimated tumor diameter \>5cm on brain image.
  • Age between 18-65 years.
  • American Society of Anaesthesiologist (ASA) physical status Ⅰ to Ⅲ
  • Obtain written informed consent.

You may not qualify if:

  • Allergic to tranexamic acid.
  • History of thrombotic disease.
  • History of chronic kidney disease
  • Receiving other anticoagulation or antiplatelet treatment.
  • Refuse to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (1)

  • Yu H, Liu M, Zhang X, Ma T, Yang J, Wu Y, Wang J, Li M, Wang J, Zeng M, Zhang L, Jin H, Liu X, Li S, Peng Y. The effect of tranexamic acid on intraoperative blood loss in patients undergoing brain meningioma resections: Study protocol for a randomized controlled trial. PLoS One. 2023 Aug 31;18(8):e0290725. doi: 10.1371/journal.pone.0290725. eCollection 2023.

    PMID: 37651373DERIVED

MeSH Terms

Conditions

Meningioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System Diseases

Study Officials

  • Shu Li, M.D.

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu Li, M.D.

CONTACT

8613699223065lishu@bjtth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Professor

Study Record Dates

First Submitted

January 5, 2022

First Posted

February 8, 2022

Study Start

June 15, 2022

Primary Completion

December 30, 2024

Study Completion

June 30, 2025

Last Updated

August 29, 2022

Record last verified: 2022-08

Locations

CN(1)