Aspin: neurosurgical aspirin intervention prognostic study — perioperative continuation versus discontinuation of aspirin in lumbar spinal surgery, a randomized controlled, noninferiority trial

AbstractRationaleAspirin is typically discontinued in cranial and spinal surgery because of the increased risk of hemorrhagic complications, but comes together with the risk of resulting in an increase of cardiac and neurologic thrombotic perioperative events.ObjectiveThe aim of this study is to investigate the non-inferiority of perioperative continuation of aspirin patients undergoing low complex lumbar spinal surgery, compared with the current policy of perioperative discontinuation of aspirin.Study designA randomized controlled trial with two parallel groups of 277 cases (554 in total).Study populationPatients undergoing low complex lumbar spinal surgery and using aspirin. All patients are aged>18 years.InterventionPeri-operative continuation of aspirin.Study outcomesPrimary study outcome: composite of the following bleeding complications:Neurological deterioration as a result of hemorrhage in the surgical area with cauda and/or nerve root compression.Post-surgical anemia with hemoglobin level lower than 5 mmol/l, requiring transfusion.Subcutaneous hematoma leading to wound leakage and pain higher than NRS=7.Major and/or minor hemorrhage in any other body system according to the definition of the International Society on Thrombosis and Haemostasis bleeding scale.Secondary study outcomes:Each of the individual components of the primary outcomeAbsolute mean difference in operative blood loss between the study armsThrombo-embolic-related complications:Myocardial infarctio...
Source: Trials - Category: Research Source Type: clinical trials