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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TXA group | Active Comparator | The TXA group will receives Tranexamic acid intraoperative. |
|
| Placebo group | Placebo Comparator | The TXA group will receives 0.9% saline intraoperative. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | 20mg/kg TXA was prepared in a 50ml syringe for intravenous pump |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Early postoperative seizures within 7 days | 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. | Within 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of non-epileptic complications | Including intracranial hematoma, deep vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, stroke, myocardial infarction, acute kidney infarction, anaemia, and infection. | Within 7 days after the intervention |
| Estimated intraoperative blood loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuming Peng, M.D., Ph.D | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | Beijing Municipality | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37857168 | Derived | Li S, Liu M, Yang J, Yan X, Wu Y, Zhang L, Zeng M, Zhou D, Peng Y, Sessler DI. Intravenous tranexamic acid for intracerebral meningioma resections: A randomized, parallel-group, non-inferiority trial. J Clin Anesth. 2024 Feb;92:111285. doi: 10.1016/j.jclinane.2023.111285. Epub 2023 Oct 17. | |
| 35110315 | Derived |
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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.
Two years after the primary outcome data is published.
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| ID | Term |
|---|---|
| D012640 | Seizures |
| D008579 | Meningioma |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 0.9% saline |
| Drug |
0.9% saline was prepared in a 50ml syringe for intravenous pump |
|
Estimated intraoperative blood loss = collected blood volume in the suction canister (ml) - volume of flushing (ml) + volume from gauze tampon (ml). |
| During surgery |
| The changes in haemoglobin concentrations | The changes in haemoglobin concentrations between baseline and end of surgery. | During surgery |
| The intraoperative blood transfusion volume and rate | The intraoperative blood transfusion volume and rate. | During surgery |
| The intraoperative cell saver volume and rate | The intraoperative cell saver volume and rate. | During surgery |
| Li S, Yan X, Li R, Zhang X, Ma T, Zeng M, Dong J, Wang J, Liu X, Peng Y. Safety of intravenous tranexamic acid in patients undergoing supratentorial meningiomas resection: protocol for a randomised, parallel-group, placebo control, non-inferiority trial. BMJ Open. 2022 Feb 2;12(2):e052095. doi: 10.1136/bmjopen-2021-052095. |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |