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Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection

Primary Purpose

Tranexamic Acid, Intraoperative Blood Loss, Meningioma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Continous infusion
Single infusion
Placebo
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tranexamic Acid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Tiantan Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Continous infusion group

Single infusion group

Placebo group

Arm Description

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

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

Infusion with same volume of 0.9% saline.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
January 5, 2022
Last Updated
August 24, 2022
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05230381
Brief Title
Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection
Official Title
Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Brain Meningioma Resections: Study Protocol of a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tranexamic Acid, Intraoperative Blood Loss, Meningioma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continous infusion group
Arm Type
Active Comparator
Arm Description
Infusion with 20mg/kg tranexamic acid and 5mg/kg/h tranexamic acid.
Arm Title
Single infusion group
Arm Type
Active Comparator
Arm Description
Infusion with 20mg/kg tranexamic acid and same volume 0.9% saline.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Infusion with same volume of 0.9% saline.
Intervention Type
Drug
Intervention Name(s)
Continous infusion
Intervention Description
The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by 5mg/kg/h tranexamic acid infusion.
Intervention Type
Drug
Intervention Name(s)
Single infusion
Intervention Description
The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by same volume of 0.9% saline.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The 0.9% saline is administered with the same volume at the same speed as the other group.
Primary Outcome Measure Information:
Title
Estimated intra-operative blood loss
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu Li, M.D.
Phone
8613699223065
Email
lishu@bjtth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu Li, M.D.
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu Li, M.D.
Phone
13699223065
Email
lishu@bjtth.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection

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