The protocol of FINISH (Finnish study of intraoperative irrigation versus drain alone after evacuation of chronic subdural haematoma, NCT04203550) was published in BMJ Open. FINISH is a pragmatic nationwide randomised controlled trial to assess the role of intraoperative irrigation in the operative treatment of chronic subdural hematomas.
“Chronic subdural hematomas are one of the most common neurosurgical emergencies. Still, we have really little evidence to support current ways of treating these hematomas”, says Dr. Lönnrot, the PI of the project.
Annually about 400–500 patients with chronic subdural hematomas are operated in Finland.
“This number is expected to increase due to the ageing population and increased use of antithrombotic medications, which are the strongest risk factors for these bleedings”, medical and PhD student Tommiska says.
FINISH is designed as a non-inferiority trial with the hypothesis of no-irrigation not leading to any increase in the rate of hematomas requiring re-operations within 6-months of the primary surgery.
The study started in January 2020 at HUS. Oulu and Kuopio University Hospitals will start to recruit during the summer. Turku and Tampere will follow during the autumn. To date, 60 patients have been enrolled and operated. The first interim analysis is expected to be finished late 2020.