Back to resultsThe Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection (STAMP)
Primary Purpose
Seizures, Meningioma
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tranexamic acid
0.9% saline
Sponsored by
About this trial
This is an interventional treatment trial for Seizures focused on measuring meningioma, blood management
Eligibility Criteria
Inclusion Criteria:
- 1) age 18-80 years
- 2) American Society of Anesthesiologist (ASA) classification score I~III
Exclusion Criteria:
- 1) allergic to tranexamic acid
- 2) preoperative seizures
- 3) history of thrombotic disease
- 4) chronic kidney disease
- 5) breastfeeding or pregnancy
- 6) refuse to participate in the study
Sites / Locations
- Beijing Tiantan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
TXA group
Placebo group
Arm Description
The TXA group will receives Tranexamic acid intraoperative.
The TXA group will receives 0.9% saline intraoperative.
Outcomes
Primary Outcome Measures
Early postoperative seizures within 7 days
Postoperative seizures were defined as a transient occurrence of involuntary movements, abnormal sensory phenomena, or an altered mental status that could not otherwise be explained.
Secondary Outcome Measures
The incidence of non-epileptic complications
Including intracranial hematoma, deep vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, stroke, myocardial infarction, acute kidney infarction, anaemia, and infection.
Estimated intraoperative blood loss
Estimated intraoperative blood loss = collected blood volume in the suction canister (ml) - volume of flushing (ml) + volume from gauze tampon (ml).
The changes in haemoglobin concentrations
The changes in haemoglobin concentrations between baseline and end of surgery.
The intraoperative blood transfusion volume and rate
The intraoperative blood transfusion volume and rate.
The intraoperative cell saver volume and rate
The intraoperative cell saver volume and rate.
Full Information
NCT ID
NCT04595786
First Posted
October 9, 2020
Last Updated
January 1, 2023
Sponsor
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04595786
Brief Title
The Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection
Acronym
STAMP
Official Title
A Randomized, Parallel-group, Placebo Control, Non-inferiority Trial to Investigate the Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
February 24, 2023 (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
Growing evidence of Tranexamic Acid (TXA) being used to reduce blood loss and blood transfusions in various guidelines. However, the adverse effects of TXA especially seizure has always been a problem of concern, especially in neurosurgery. Therefore, this study aims to provide a scientific evidence for the safety of TXA in supratentorial meningiomas resection patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures, Meningioma
Keywords
meningioma, blood management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TXA group
Arm Type
Active Comparator
Arm Description
The TXA group will receives Tranexamic acid intraoperative.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The TXA group will receives 0.9% saline intraoperative.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
20mg/kg TXA was prepared in a 50ml syringe for intravenous pump
Intervention Type
Drug
Intervention Name(s)
0.9% saline
Intervention Description
0.9% saline was prepared in a 50ml syringe for intravenous pump
Primary Outcome Measure Information:
Title
Early postoperative seizures within 7 days
Description
Postoperative seizures were defined as a transient occurrence of involuntary movements, abnormal sensory phenomena, or an altered mental status that could not otherwise be explained.
Time Frame
Within 7 days after surgery
Secondary Outcome Measure Information:
Title
The incidence of non-epileptic complications
Description
Including intracranial hematoma, deep vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, stroke, myocardial infarction, acute kidney infarction, anaemia, and infection.
Time Frame
Within 7 days after the intervention
Title
Estimated intraoperative blood loss
Description
Estimated intraoperative blood loss = collected blood volume in the suction canister (ml) - volume of flushing (ml) + volume from gauze tampon (ml).
Time Frame
During surgery
Title
The changes in haemoglobin concentrations
Description
The changes in haemoglobin concentrations between baseline and end of surgery.
Time Frame
During surgery
Title
The intraoperative blood transfusion volume and rate
Description
The intraoperative blood transfusion volume and rate.
Time Frame
During surgery
Title
The intraoperative cell saver volume and rate
Description
The intraoperative cell saver volume and rate.
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) age 18-80 years
2) American Society of Anesthesiologist (ASA) classification score I~III
Exclusion Criteria:
1) allergic to tranexamic acid
2) preoperative seizures
3) history of thrombotic disease
4) chronic kidney disease
5) breastfeeding or pregnancy
6) refuse to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuming Peng, M.D., Ph.D
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual, de-identified participant data will be shared two years after the publication of primary outcome data, by request from any qualified investigator following approval of a protocol, statistical analysis plan, and receipt of a signed data access agreement via the research office and the Beijing Tiantan Hospital Ethics Committees for the project and data release.
IPD Sharing Time Frame
Two years after the primary outcome data is published.
Citations:
PubMed Identifier
35110315
Citation
Li S, Yan X, Li R, Zhang X, Ma T, Zeng M, Dong J, Wang J, Liu X, Peng Y. Safety of intravenous tranexamic acid in patients undergoing supratentorial meningiomas resection: protocol for a randomised, parallel-group, placebo control, non-inferiority trial. BMJ Open. 2022 Feb 2;12(2):e052095. doi: 10.1136/bmjopen-2021-052095.
Results Reference
derived
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The Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection
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