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RecruitingNCT05230381Updated Aug 29, 2022

Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection

An interventional study of Continous infusion and Single infusion in Tranexamic Acid, Intraoperative Blood Loss and Meningioma, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-08-29.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2022; still recruiting 4 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
228
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tranexamic Acid
  • Intraoperative Blood Loss
  • Meningioma
03

In context

Meningioma

226 studies on the registry are indexed under Meningioma; 87 are open to participants now.

This study's planned enrollment of 228 is above the median of 40 across 161 interventional studies indexed under Meningioma.

Browse Meningioma studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
228 participants (estimated)

Study arms

  • Active comparator
    Continous infusion group

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

    Drug: Continous infusion

  • Active comparator
    Single infusion group

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

    Drug: Single infusion

  • Placebo comparator
    Placebo group

    Infusion with same volume of 0.9% saline.

    Drug: Placebo

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.

06

What researchers measure

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).

    Time frame: During surgery

07

Study locations

1 of 1 sites recruiting
  • Beijing Tiantan Hospital, Capital Medical University
    Beijing, Beijing 100070, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05230381
Lead sponsor
Beijing Tiantan Hospital
Responsible party
Shu Li (Associate Clinical Professor, Beijing Tiantan Hospital) — Principal investigator
First posted
Feb 8, 2022
Start date
Jun 15, 2022
Primary completion
Dec 30, 2024 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Aug 29, 2022

Study contacts

Shu Li, M.D.
Contact
lishu@bjtth.org
8613699223065
Shu Li, M.D.
principal investigator · Beijing Tiantan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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