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Tranexamic Acid Reduce Blood Loss in Meningioma Resection

Study Purpose

In neurosurgical setting, a large sample size trials of tranexamic acid (TXA) has been limited to TBI and SAH. The evidence of TXA in brain tumor was scarce. A few case reports support the role of TXA in brain tumor patients with significant intraoperative bleeding and difficult achieving hemostasis. To prove the benefit of TXA for an attenuation of blood loss in brain tumor patients, research with a larger sample size is required. This prospective, randomized double-blind controlled study will be conducted to evaluate the effect of TXA in reducing blood loss and blood transfusion in patients with intracranial meningiomas, diameter > 5 cm in at least 2 dimensions from the latest radiographic findings.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - The patients whose aged 18 to 60 years.
  • - The patients who was diagnosed intracranial meningioma.
  • - The radio-graphic finding of tumor diameter > 5 cm in at least 2 dimensions.
  • - The patients have written informed consent.
  • - The patients is scheduled for elective craniotomy to remove tumor.

Exclusion Criteria:

  • - Patients who refuse to participate in this study.
  • - Patients with recurrent tumor.
  • - The patient is set operation for intracranial tissue biopsy.
  • - The patients with history of TXA allergy.
  • - The pregnant patients.
  • - The patients with history of significant thromboembolic episode.
- The patients with significant renal dysfunction (GFR ≤ 50 ml/min)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04386642
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Chiang Mai University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Pathomporn Pin-on, MD
Principal Investigator Affiliation Chiang Mai University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries Thailand
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Meningioma
Additional Details

Background and Literature review: 1. Meningioma. 2. Coagulation in craniotomy to remove meningioma. 3. Bleeding in craniotomy to remove meningioma. 4. Tranexamic acid (TXA) 5. Knowledge gap The topics shown above has been reviewed to conduct a prospective randomized double-blind, placebo controlled study. To prove the study hypothesis: Will intraoperative TXA administration in adult patients scheduled for craniotomy to remove large meningioma decrease blood loss?

Arms & Interventions

Arms

Experimental: Experiment group

Each ampule contains TXA 250 mg. TXA preparation is 2000 mg dilute in normal saline 50 ml to get the concentration of 40 mg/ml. TXA will be administered 20 mg/kg loading over 20 min before skin incision followed by a maintenance infusion of 0.025 ml/kg/h (1 mg/kg/h) until the end of operation.

Placebo Comparator: Control group

Normal saline solution 50 ml is prepared in a clear 50 ml syringe similar to the experiment group.

Interventions

Drug: - Tranexamic acid

Tranexamic acid 2000 mg dilute in normal saline solution 50 ml.

Drug: - Placebo

normal saline solution in a clear 50-ml syringe

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Chiang Mai University, Chiang Mai, Thailand

Status

Address

Chiang Mai University

Chiang Mai, , 50200

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