- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05230381
Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection
August 24, 2022 updated by: Shu Li, Beijing Tiantan Hospital
Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Brain Meningioma Resections: Study Protocol of a Randomised Controlled Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
228
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shu Li, M.D.
- Phone Number: 8613699223065
- Email: lishu@bjtth.org
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100070
- Recruiting
- Beijing Tiantan Hospital, Capital Medical University
-
Contact:
- Shu Li, M.D.
- Phone Number: 13699223065
- Email: lishu@bjtth.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Continous infusion group
Infusion with 20mg/kg tranexamic acid and 5mg/kg/h tranexamic acid.
|
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.
|
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.
|
The 0.9% saline is administered with the same volume at the same speed as the other group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Estimated intra-operative blood loss
Time Frame: During surgery
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shu Li, M.D., Beijing Tiantan Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2022
Primary Completion (Anticipated)
December 30, 2024
Study Completion (Anticipated)
June 30, 2025
Study Registration Dates
First Submitted
January 5, 2022
First Submitted That Met QC Criteria
February 6, 2022
First Posted (Actual)
February 8, 2022
Study Record Updates
Last Update Posted (Actual)
August 29, 2022
Last Update Submitted That Met QC Criteria
August 24, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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