STAMP: The Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04595786

Collaborator

(none)

600

Enrollment

Location

Arms

Anticipated Duration (Months)

26.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Seizures Meningioma	Drug: Tranexamic acid Drug: 0.9% saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 30, 2020

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TXA group The TXA group will receives Tranexamic acid intraoperative.	Drug: Tranexamic acid 20mg/kg TXA was prepared in a 50ml syringe for intravenous pump
Placebo Comparator: Placebo group The TXA group will receives 0.9% saline intraoperative.	Drug: 0.9% saline 0.9% saline was prepared in a 50ml syringe for intravenous pump

Arm

Intervention/Treatment

Active Comparator: TXA group

The TXA group will receives Tranexamic acid intraoperative.

Drug: Tranexamic acid

20mg/kg TXA was prepared in a 50ml syringe for intravenous pump

Placebo Comparator: Placebo group

The TXA group will receives 0.9% saline intraoperative.

Drug: 0.9% saline

0.9% saline was prepared in a 50ml syringe for intravenous pump

Outcome Measures

Primary Outcome Measures

Early postoperative seizures within 7 days [Within 7 days after surgery]
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

Postoperative complications [7 days after surgery]
including intracranial hematoma, deep vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, stroke, myocardial infarction, acute kidney infarction, anaemia, and infection.
Haemoglobin changes [During surgery]
The changes in haemoglobin concentrations between baseline and end of surgery
Intraoperative blood loss [During surgery.]
Estimated intraoperative blood loss = collected blood volume in the suction canister (ml) - volume of flushing (ml) + volume from gauze tampon (ml).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. age 18-80 years
1. American Society of Anesthesiologist (ASA) classification score I~III

Exclusion Criteria:

1. allergic to tranexamic acid
1. preoperative seizures
1. history of thrombotic disease
1. chronic kidney disease
1. breastfeeding or pregnancy
1. refuse to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tiantan Hospital	Beijing	Beijing	China	100070

Sponsors and Collaborators

Beijing Tiantan Hospital

Investigators

Principal Investigator: Yuming Peng, M.D., Ph.D, Beijing Tiantan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yuming Peng, Deputy chief of Department of Anesthesiology, Beijing Tiantan Hospital

ClinicalTrials.gov Identifier:

NCT04595786

Other Study ID Numbers:

ChiECRCT20200224

First Posted:

Oct 22, 2020

Last Update Posted:

Oct 22, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

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

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

Keywords provided by Yuming Peng, Deputy chief of Department of Anesthesiology, Beijing Tiantan Hospital

meningioma

blood management

Additional relevant MeSH terms:

Meningioma

Seizures

Tranexamic Acid

Study Results

No Results Posted as of Oct 22, 2021