NCT04386642

Tranexamic Acid Reduce Blood Loss in Meningioma Resection

Effect of Tranexamic Acid Infusion to Reduce Intraoperative Blood Loss in Large Meningioma: A Prospective Randomized Double-blind Control Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Chiang Mai University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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?

Conditions

• Meningioma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-07-31
• Completion: 2022-09-30
• First posted: 2020-05-13
• Last updated: 2021-01-27

Locations

1 site across 1 country: Thailand