Meningioma Clinical Trial
Official title:
Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Brain Meningioma Resections: Study Protocol of a Randomised Controlled Trial
NCT number | NCT05230381 |
Other study ID # | 2022018 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 15, 2022 |
Est. completion date | June 30, 2025 |
Intra-operative blood loss of huge meningioma resection patients on average was over 1000ml. Intra-operative massive hemorrhage was associated with longer hospital of stay, higher expense, and higher mortality. Previous studies indicated intra-operative tranexamic acid infusion would decrease blood loss for cardiac, trauma and obstetric procedures. However, limited researches focusing on the effect of tranexamic acid in neurosurgery population, with heterogenous pathologies. The purpose of this study was to investigate the effect of tranexamic acid on intra-operative blood loss in patients undergoing huge meningioma resection.
Status | Recruiting |
Enrollment | 228 |
Est. completion date | June 30, 2025 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients undergoing elective supratentorial meningioma resection with estimated tumor diameter >5cm on brain image. - Age between 18-65 years. - American Society of Anaesthesiologist (ASA) physical status ? to ? - Obtain written informed consent. Exclusion Criteria: - Allergic to tranexamic acid. - History of thrombotic disease. - History of chronic kidney disease - Receiving other anticoagulation or antiplatelet treatment. - Refuse to provide written informed consent |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tiantan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Estimated intra-operative blood loss | Estimated intra-operative blood loss is assessed as following formula:collected blood volume in the suction canister (mL) - the volume of flushing (mL) + the volume from gauze tampon (mL). | During surgery |
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