Meningioma, Seizures
Conditions
Keywords
meningioma, blood management
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.
Interventions
DRUGTranexamic acid
20mg/kg TXA was prepared in a 50ml syringe for intravenous pump
DRUG0.9% saline
0.9% saline was prepared in a 50ml syringe for intravenous pump
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early postoperative seizures within 7 days | 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
| Measure | Time frame | Description |
|---|---|---|
| The changes in haemoglobin concentrations | During surgery | The changes in haemoglobin concentrations between baseline and end of surgery. |
| The incidence of non-epileptic complications | Within 7 days after the intervention | Including intracranial hematoma, deep vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, stroke, myocardial infarction, acute kidney infarction, anaemia, and infection. |
| Estimated intraoperative blood loss | During surgery | Estimated intraoperative blood loss = collected blood volume in the suction canister (ml) - volume of flushing (ml) + volume from gauze tampon (ml). |
| The intraoperative blood transfusion volume and rate | During surgery | The intraoperative blood transfusion volume and rate. |
| The intraoperative cell saver volume and rate | During surgery | The intraoperative cell saver volume and rate. |
Countries
China
Outcome results
None listed