Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05230381

Collaborator

(none)

228

Enrollment

Location

Arms

36.5

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tranexamic Acid Intraoperative Blood Loss Meningioma	Drug: Continous infusion Drug: Single infusion Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

228 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effect of Intravenous Tranexamic Acid in Patients Undergoing Huge Meningiomas Resection: a Randomised Controlled Trial

Actual Study Start Date :

Jun 15, 2022

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Continous infusion group Infusion with 20mg/kg tranexamic acid and 5mg/kg/h tranexamic acid.	Drug: Continous infusion The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by 5mg/kg/h tranexamic acid infusion.
Active Comparator: Single infusion group Infusion with 20mg/kg tranexamic acid and same volume 0.9% saline.	Drug: Single infusion The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by same volume of 0.9% saline.
Placebo Comparator: Placebo group Infusion with same volume of 0.9% saline.	Drug: Placebo The 0.9% saline is administered with the same volume at the same speed as the other group.

Arm

Intervention/Treatment

Active Comparator: Continous infusion group

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

Drug: Continous infusion

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

Active Comparator: Single infusion group

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

Drug: Single infusion

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

Placebo Comparator: Placebo group

Infusion with same volume of 0.9% saline.

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Estimated intra-operative blood loss [During surgery]
Estimated intra-operative blood loss is assessed as following formula:Estimated intraoperative blood loss = volume in suction canisters -weight of blood-soaked sponges -drapes-volume of wash fluid

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing selective meningioma resection with estimated tumor diameter >5cm on brain image.
Age between 18-80 years.
Obtain written informed consent.

Exclusion Criteria:

Allergic to tranexamic acid.
History of embolic or thrombotic disease.
History of traumatic brain injury or neurosurgery.
Receiving other anticoagulation or antiplatelet treatment.
Severe hepatic or renal dysfunction.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing	China	100070

Sponsors and Collaborators

Beijing Tiantan Hospital

Investigators

Principal Investigator: Shu Li, M.D., Beijing Tiantan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shu Li, Associate Clinical Professor, Beijing Tiantan Hospital

ClinicalTrials.gov Identifier:

NCT05230381

Other Study ID Numbers:

2022018

First Posted:

Feb 8, 2022

Last Update Posted:

Jul 12, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Meningioma

Hemorrhage

Study Results

No Results Posted as of Jul 12, 2022