Tranexamic acid vs. embolization of the meningeal artery as an adjunctive therapeutic regime to reduce the recurrence rate after surgical relief of chronic subdural hematomas (TABASCO)-a randomized controlled trial.

backgroundChronic subdural hematoma is a persistent, bloody to serous fluid retention in the subdural space between the dura mater and arachnoid mater, usually caused by an initial trauma, and is one of the most common traumatic intracranial hemorrhages in western industrialized nations. In the event of a compressive effect on the brain, the hematoma is usually relieved by means of a burr hole trephination. In view of the high postoperative recurrence rate, conservative treatment methods have been investigated both as a competitor to surgery alone in cases where the indication for surgery is debatable and as a supportive therapy for surgical hematoma relief. Studies on embolization of the middle meningeal artery during surgery as well as studies on postoperative drug therapy using tranexamic acid have shown the most promise. However, there is currently a lack of studies that randomly compare the effectiveness of these two perioperative treatment strategies regarding to their efficacy in avoiding revision surgery and the safety of the respective procedure.

methodsTABASCO is a prospective, randomized, two-arm, multicenter, clinical trial designed to determine whether postoperative treatment of chronic subdural hematomas using adjuvant drug therapy with tranexamic acid (test group) is equivalent to postoperative embolization of the arteria meningea media (control group) in terms of postoperative volume reduction of the hematoma and the need for revision surgery of CSDH. Patients over 18 years of age who have undergone surgery for CSDH for the first time no more than 24 h before inclusion in the study will be randomized 1:1 to the test group or control group. The primary endpoint is the postoperative volume decrease of a primarily surgically relieved CSDH quantitatively and regarding to the time course on the affected side in a study period of 3 months postoperatively. The secondary endpoint of this study is to investigate the extent to which the rate of necessary revision surgery can be influenced by the adjuvant therapy procedures over the course of 3 months. The tertiary endpoint is the neurological outcome of the patients included in the study and assigned to the different treatment arms after a total follow-up period of 3 months as well as the complication rate of the adjuvant procedures used. Assuming a risk difference of 8% for rebleeding and surgical revision, with an applied power of 80%, 276 patients (138 per group) will be included in this study. DISCUSSION: The TABASCO study will provide clinical evidence as to whether embolization of the middle meningeal artery in addition to surgery is comparable to postoperative drug therapy using tranexamic acid as an adjuvant treatment method for operated chronic subdural hematomas in terms of hematoma volume reduction, revision rate and safety of the procedures.

trial registrationGerman Clinical Trials Registry (Deutsches Register Klinischer Studien (DRKS)) DRKS00033515. Registered on 05 Feb 2024.