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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04595786
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2021
Sponsor:
Information provided by (Responsible Party):
Yuming Peng, Beijing Tiantan Hospital

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 30, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Early postoperative seizures within 7 days [ Time Frame: 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 :
  1. Postoperative complications [ Time Frame: 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.

  2. Haemoglobin changes [ Time Frame: During surgery ]
    The changes in haemoglobin concentrations between baseline and end of surgery

  3. Intraoperative blood loss [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04595786


Contacts
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Contact: Yuming Peng, M.D., Ph.D 8610-59976658 florapym766@163.com

Locations
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China, Beijing
Beijing Tiantan Hospital Recruiting
Beijing, Beijing, China, 100070
Contact: Yuming Peng, M.D.,PhD.       florapym766@163.com   
Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
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Principal Investigator: Yuming Peng, M.D., Ph.D Beijing Tiantan Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yuming Peng, Deputy chief of Department of Anesthesiology, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT04595786    
Other Study ID Numbers: ChiECRCT20200224
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Two years after the primary outcome data is published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuming Peng, Beijing Tiantan Hospital:
meningioma
blood management
Additional relevant MeSH terms:
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Meningioma
Seizures
Neurologic Manifestations
Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
 Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants