The Finnish Study of Intraoperative Irrigation Versus Drain Alone After Evacuation of Chronic Subdural Hematoma (FINISH)

Not Applicable

Completed

• Conditions: Chronic Subdural Hematoma
• Interventions: Procedure: No irrigation; Procedure: Intraoperative irrigation

• Registration Number: NCT04203550
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-18
• Study Start: 2020-01-01
• Primary Completion: 2023-02-14
• Study Completion: 2023-02-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-18
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 587

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No-Irrigation group (N-IR)	No irrigation	A burr-hole craniostomy is performed and a small incision to the dura is made and 10 ml of subdural exudate is aspired with blunt aspiration needle for a CSDH sample to be stored in -70℃ to be used for later analysis. The subdural drain is inserted approximately 3-5 cm underneath the skull and parallel to it. The duration of operation is recorded.
Irrigation group (IR)	Intraoperative irrigation	A burr-hole craniostomy is performed and the dura is opened sharply and 10 ml of subdural exudate is aspired with blunt aspiration needle for a CSDH sample to be stored in -70℃ to be used for later analysis. Subdural space is irrigated by repeated rinsing with body temperature saline solution with a syringe and blunt needle until surgeon considers exudate to be clear. Minimum volume of irrigation will be 200 ml per operated side. The subdural drain is inserted 3-5 cm underneath the skull and parallel to it. The total volume of irrigation as well as the duration of operation is recorded.

Primary Outcome Measures

Name	Time	Method
Rate of re-operations of ipsilateral chronic subdural hematoma	From operation up to 6 months after postoperatively	Rate of reoperations between groups

Secondary Outcome Measures

Name	Time	Method
Rate of complications and adverse events within 6 months	within 6 months after operation	Rate of complication rate between groups
Change in the volume of CSDH in the CT or MRI image between baseline and 2 months post-operatively	Immediate preoperative and 2 months postoperatively	The volume of CSDH will be measured from preoperative CT or MRI and at 2 months after operation CT or MRI
Change of Modified Rankin Scale (MRS) from baseline to 6 months after operation	At baseline, and at 2 and 6 months after operation	Modified Rankin scale ranges from 1 to 6, where 1 indicates normal daily functionality and 6 indicates death
Rate of mortality between intervention groups	From operation up to 6 months postoperatively	Rate of mortality between intervention groups
Duration of the operation between groups	Intraoperative measure	Time (minutes) used to complete the operation, from incision to last suture
Hospital length of stay between groups	From operation up to six months	The duration of the stay in hospital (days)

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland