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

NCT04203550 | Completed DMC

• 1 other identifier: 3035/2019
• Study Type: interventional
• Target: 587
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Subdural Hematoma

Keywords

Chronic Subdural hematoma; Surgical evacuation; Recurrence; Irrigation fluid

Outcome Measures

Primary Outcomes (1)

• Rate of re-operations of ipsilateral chronic subdural hematoma

  Rate of reoperations between groups

  From operation up to 6 months after postoperatively

Secondary Outcomes (6)

• Change of Modified Rankin Scale (MRS) from baseline to 6 months after operation

  At baseline, and at 2 and 6 months after operation

• Rate of mortality between intervention groups

  From operation up to 6 months postoperatively

• Duration of the operation between groups

  Intraoperative measure

• Hospital length of stay between groups

  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

  Immediate preoperative and 2 months postoperatively

Study Arms (2)

Irrigation group (IR)

ACTIVE COMPARATOR

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

No-Irrigation group (N-IR)

EXPERIMENTAL

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

Interventions

Intraoperative irrigation PROCEDURE

Operation with irrigation

Irrigation group (IR)

No irrigation PROCEDURE

Operation without irrigation

No-Irrigation group (N-IR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Turku University Hospital: collaborator
• Oulu University Hospital: collaborator
• Tampere University Hospital: collaborator
• Kuopio University Hospital: collaborator

Study Sites (1)

Helsinki University Hospital

Helsinki, Finland

Location

Related Publications (5)

• Tommiska P, Knuutinen O, Lonnrot K, Luoto T, Leinonen V, Koivisto T, Tetri S, Posti JP, Raj R; FINISH study group. Mortality and causes of death after surgery for chronic subdural hematoma: a post hoc study of the FINISH randomized trial. Acta Neurochir (Wien). 2025 Dec 1;167(1):310. doi: 10.1007/s00701-025-06728-9.

  PMID: 41326886 DERIVED

• Knuutinen O, Maatta J, Kovalainen A, Pohjola A, Tommiska P, Raj R; FINISH study group. Surgical Delay and Functional Outcome After Surgery for Chronic Subdural Hematoma. World Neurosurg. 2025 May;197:123843. doi: 10.1016/j.wneu.2025.123843. Epub 2025 Feb 28.

  PMID: 40024327 DERIVED

• Tommiska P, Knuutinen O, Lonnrot K, Kivisaari R, Raj R; FINISH study group. Association between postoperative thromboembolic and hemorrhagic complications and clinical outcomes after surgery for chronic subdural hematoma in patients with anticoagulation therapy for atrial fibrillation. Acta Neurochir (Wien). 2025 Jan 16;167(1):17. doi: 10.1007/s00701-024-06417-z.

  PMID: 39815109 DERIVED

• Raj R, Tommiska P, Koivisto T, Leinonen V, Danner N, Posti JP, Laukka D, Luoto T, Rauhala M, Tetri S, Korhonen TK, Satopaa J, Kivisaari R, Luostarinen T, Schwartz C, Czuba T, Taimela S, Lonnrot K, Jarvinen TLN; Finnish study of intraoperative irrigation versus drain alone after evacuation of CSDH (FINISH) study group. Burr-hole drainage with or without irrigation for chronic subdural haematoma (FINISH): a Finnish, nationwide, parallel-group, multicentre, randomised, controlled, non-inferiority trial. Lancet. 2024 Jun 29;403(10446):2798-2806. doi: 10.1016/S0140-6736(24)00686-X. Epub 2024 Jun 6.

  PMID: 38852600 DERIVED

• 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.

  PMID: 32565480 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Recurrence

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Kimmo Lönnrot, MD, Ph.D

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the treatment, it is not possible to blind the surgeon and OR staff from the treatment allocation. Measures to minimize bias include: * The patient will not be informed of treatment allocation * Treatment allocation will not be documented in medical records i.e. all the personnel participating in patient care after operation will be blinded to allocation * The study group members collecting postoperative data and performing the statistical analyses will be blinded to treatment arm until the analyses are finished.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized, controlled, parallel group non-inferiority trial.

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: January 1, 2020
• Primary Completion: February 14, 2023
• Study Completion: February 14, 2023
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• Access Criteria: Data access request will be reviewed by FINISH-trial steering group. Requestors will be required to sign a Data Access Agreement.

Locations

FI (1)