Why is this trial needed?
Surgery for chronic subdural haematomas (CSDHs) is the most common emergency neurosurgical procedure. CSDHs are typically caused by minor head trauma, leading to a haemorrhage in between the dura mater and the arachnoid membrane. For symptomatic CSDHs, the treatment is burr-hole evacuation, followed by intraoperative irrigation and placement of a subdural drainage.
Although irrigation is widely considered an imperative (‘uncontested’) part of the surgical procedure, the true value of irrigation has never been established in a randomized controlled trial setting. In the FINISH trial, we will compare single burr-hole evacuation of CSDH, subsequent intraoperative irrigation and the use of a drain to evacuation of CSDH without irrigation (drain alone).
What is the primary objective of the FINISH trial?
The aim of this trial is to study whether intraoperative irrigation adds any benefit to simple evacuation and subsequent drainage in the treatment of CSDHs. FINISH is a non-inferiority trial. The primary outcome is symptomatic CSDH recurrence requiring reoperation within 6 months. If there is no difference in recurrence rates between intraoperative irrigation and no irrigation, CSDH surgery can be performed faster and more safely by omitting the need to irrigate.
Where are we now?
We started recruiting patients in January 2020, first at the Helsinki University Hospital. Since the beginning of October (2020), the trial has been up and running in all five neurosurgical centres in Finland.
The FINISH trial protocol was published in BMJ Open earlier this year