Clinical trial NCT04203550: The Finnish Study of Intraoperative Irrigation Versus Drain Alone After Evacuation of Chronic Subdural Hematoma (FINISH)
Official title: The Finnish Study of Intraoperative Irrigation Versus Drain Alone After Evacuation of Chronic Subdural Hematoma (FINISH): a Study Protocol for a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Subdural Hematoma
Keywords: Chronic Subdural hematoma
Surgical evacuation
Recurrence
Irrigation fluid
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
name: Oulu University Hospital
name: Tampere University Hospital
name: Kuopio University Hospital
First posted: 2019-12-18
Enrollment: 587
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled, parallel group non-inferiority trial.
Primary purpose: TREATMENT

Brief summary: FINISH-trial is a prospective, randomized, controlled, parallel group non-inferiority trial comparing single burr-hole evacuation of chronic subdural hematoma (CSDH) with intraoperative irrigation (IR) and evacuation of CSDH without irrigation (N-IR).

Detailed description: FINISH-trial is a prospective, randomized, controlled, parallel group non-inferiority trial comparing single burr-hole evacuation of chronic subdural hematoma (CSDH) with intraoperative irrigation (IR) and evacuation of CSDH without irrigation (N-IR). In both groups, a passive subdural drain is used for 48 hours as a standard of treatment. The study will be conducted in all five neurosurgical departments in Finland. To determine whether operation without irrigation results in non-inferior outcome to operation with irrigation, we will randomize 426 patients into two groups and follow them up for 6 months using recurrence rates as the primary outcome. Secondary outcomes in our study include mortality, neurological outcome and complications.

Eligibility criteria: Inclusion Criteria:

* Patients with a symptomatic unilateral or bilateral CSDH requiring burr-hole evacuation

  o Predominantly hypodense or isodense on imaging (CT/MRI).
* Clinical symptoms correlating with the CSDH
* Patients with bilaterally operated CSDHs will be treated with the same protocol on both sides and analyzed as a single study participant

Exclusion Criteria:

* CSDH requiring surgical treatment other that burr-hole evacuation (e.g. craniotomy)
* CSDH in a patient who has a cerebrospinal fluid shunt
* Patients who have undergone any intracranial surgery before
* Comatose patients (GCS 8 or lower) with absent motor responses to painful stimuli; decerebrate or decorticate posturing
* Patient's postoperative cooperation is suspected to be insufficient for drain usage, i.e. disoriented or semiconscious patient
* Patient has a hematogenic malignancy that has obtained active treatment within the previous five years
* Patient has a central nervous system tumor or malignancy
* Patient has acute infection with fever and requires antibiotic treatment at the moment
* Patient has a high risk of life-threatening thrombosis (e.g. recent coronary stent, recent pulmonary embolism, low cardiac valve replacement) and discontinuation of antithrombotic medication is not recommended

Primary outcomes:
measure: Rate of re-operations of ipsilateral chronic subdural hematoma
timeFrame: From operation up to 6 months after postoperatively
Secondary outcomes:
measure: Change of Modified Rankin Scale (MRS) from baseline to 6 months after operation
timeFrame: At baseline, and at 2 and 6 months after operation
measure: Rate of mortality between intervention groups
timeFrame: From operation up to 6 months postoperatively
measure: Duration of the operation between groups
timeFrame: Intraoperative measure
measure: Hospital length of stay between groups
timeFrame: From operation up to six months
measure: Change in the volume of CSDH in the CT or MRI image between baseline and 2 months post-operatively
timeFrame: Immediate preoperative and 2 months postoperatively
measure: Rate of complications and adverse events within 6 months
timeFrame: within 6 months after operation
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Kimmo Lönnrot, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tommiska P, Raj R, Schwartz C, Kivisaari R, Luostarinen T, Satopaa J, Taimela S, Jarvinen T, Ranstam J, Frantzen J, Posti J, Luoto TM, Leinonen V, Tetri S, Koivisto T, Lonnrot K. Finnish study of intraoperative irrigation versus drain alone after evacuation of chronic subdural haematoma (FINISH): a study protocol for a multicentre randomised controlled trial. BMJ Open. 2020 Jun 21;10(6):e038275. doi: 10.1136/bmjopen-2020-038275.