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Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection

Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Brain Meningioma Resections: Study Protocol of a Randomised Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05230381
Enrollment
228
Registered
2022-02-08
Start date
2022-06-15
Completion date
2025-06-30
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Blood Loss, Meningioma, Tranexamic Acid

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.

Interventions

DRUGContinous infusion

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

DRUGSingle infusion

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

DRUGPlacebo

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

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Estimated intra-operative blood lossDuring surgeryEstimated 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).

Countries

China

Contacts

Primary ContactShu Li, M.D.
lishu@bjtth.org8613699223065

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026