Chronic Subdural HematomaFINISHNCT04203550
The Finnish Study of Intraoperative Irrigation Versus Drain Alone After Evacuation of Chronic Subdural Hematoma (FINISH)
A study testing Intraoperative irrigation and No irrigation in people with Chronic Subdural Hematoma, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Intraoperative irrigation and No irrigation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 587 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2020to 14 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Intraoperative irrigation, No irrigation
- Keywords
- Chronic Subdural hematoma, Surgical evacuation, Recurrence, Irrigation fluid
- Medical subject headings
- Hematoma, Subdural, Chronic, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative irrigationProcedure or surgery
Operation with irrigation
No irrigationProcedure or surgery
Operation without irrigation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: No irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of re-operations of ipsilateral chronic subdural hematoma
Rate of reoperations between groups
Measured: From operation up to 6 months after postoperatively
Secondary outcomes (6)
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
Measured: At baseline, and at 2 and 6 months after operation
Rate of mortality between intervention groups
Rate of mortality between intervention groups
Measured: 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
Measured: Intraoperative measure
Hospital length of stay between groups
The duration of the stay in hospital (days)
Measured: 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
Measured: Immediate preoperative and 2 months postoperatively
Rate of complications and adverse events within 6 months
Rate of complication rate between groups
Measured: within 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Jan 2020
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled, parallel group non-inferiority trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 587 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital
- Responsible party
- Principal investigator, Kimmo Lonnrot, Helsinki University Central Hospital
- Investigators
- Kimmo Lönnrot, MD, Ph.D, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203550
- Sponsor's protocol ID
- 3035/2019
- Acronym
- FINISH
- Status last verified
- May 2024
- First submitted
- 16 Dec 2019
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) is available upon request when General Data Protection Regulation (GDPR) and guiding legislation regulations are fulfilled.
Publications
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.
PubMed 41326886Knuutinen 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.
PubMed 40024327Tommiska 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.
PubMed 39815109Raj 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.
PubMed 38852600Tommiska 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.
PubMed 32565480
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04203550
- Acronym / sponsor ID
- FINISH / 3035/2019
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Chronic Subdural hematoma, Surgical evacuation, Recurrence, Irrigation fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 587 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled, parallel group non-inferiority trial.
| Arm | Type | Receives |
|---|---|---|
| Irrigation group (IR) | Active comparator | Procedure: Intraoperative irrigationA 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. |
| No-Irrigation group (N-IR) | Experimental | Procedure: No irrigationA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative irrigationOperation with irrigation | Procedure or surgery | Irrigation group (IR) |
| No irrigationOperation without irrigation | Procedure or surgery | No-Irrigation group (N-IR) |
Primary outcome
Rate of re-operations of ipsilateral chronic subdural hematoma
Time frame: From operation up to 6 months after postoperatively
Rate of reoperations between groups
6 secondary outcomes
Change of Modified Rankin Scale (MRS) from baseline to 6 months after operation
Time frame: At baseline, and at 2 and 6 months after operation
Rate of mortality between intervention groups
Time frame: From operation up to 6 months postoperatively
Duration of the operation between groups
Time frame: Intraoperative measure
Hospital length of stay between groups
Time frame: 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
Time frame: Immediate preoperative and 2 months postoperatively
Rate of complications and adverse events within 6 months
Time frame: within 6 months after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Derived from this study: PubMed 41326886Tommiska 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.
- Derived from this study: PubMed 40024327Knuutinen 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.
- Derived from this study: PubMed 39815109Tommiska 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.
- Derived from this study: PubMed 38852600Raj 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.
- Derived from this study: PubMed 32565480Tommiska 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.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) is available upon request when General Data Protection Regulation (GDPR) and guiding legislation regulations are fulfilled.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimmo Lönnrot, MD, Ph.D principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative irrigation and No irrigation in people with Chronic Subdural Hematoma, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of re-operations of ipsilateral chronic subdural hematoma (time frame: From operation up to 6 months after postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04203550, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.