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

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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Procedure: Intraoperative irrigation; Procedure: No irrigation

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 Type: Interventional
• Enrollment (Actual): 587
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Helsinki University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Irrigation group (IR); 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.	Procedure: Intraoperative irrigation; Operation with irrigation
Experimental: No-Irrigation group (N-IR); 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.	Procedure: No irrigation; Operation without irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of re-operations of ipsilateral chronic subdural hematoma	Rate of reoperations between groups	From operation up to 6 months after postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: Turku University Hospital; Oulu University Hospital; Kuopio University Hospital; Tampere University Hospital
• Investigators: Principal Investigator: Kimmo Lönnrot, MD, Ph.D, Helsinki University Central Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): February 14, 2023
• Study Completion (Actual): February 14, 2023

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 18, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Recurrence; Surgical evacuation; Chronic Subdural hematoma; Irrigation fluid
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Chronic Disease; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic
• Other Study ID Numbers: 3035/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) is available upon request when General Data Protection Regulation (GDPR) and guiding legislation regulations are fulfilled.
• IPD Sharing Time Frame: Study protocol and Statistical Analysis Plan (SAP) will be published after the study has started. Other document will be available as study proceeds and after study is completed.
• IPD Sharing Access Criteria: Data access request will be reviewed by FINISH-trial steering group. Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No