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

Primary Purpose

Chronic Subdural Hematoma

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Intraoperative irrigation
No irrigation
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring Chronic Subdural hematoma, Surgical evacuation, Recurrence, Irrigation fluid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Irrigation group (IR)

No-Irrigation group (N-IR)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rate of re-operations of ipsilateral chronic subdural hematoma
Rate of reoperations between groups

Secondary Outcome Measures

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
Rate of mortality between intervention groups
Rate of mortality between intervention groups
Duration of the operation between groups
Time (minutes) used to complete the operation, from incision to last suture
Hospital length of stay between groups
The duration of the stay in hospital (days)
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
Rate of complications and adverse events within 6 months
Rate of complication rate between groups

Full Information

First Posted
December 16, 2019
Last Updated
July 7, 2023
Sponsor
Helsinki University Central Hospital
Collaborators
Turku University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04203550
Brief Title
The Finnish Study of Intraoperative Irrigation Versus Drain Alone After Evacuation of Chronic Subdural Hematoma (FINISH)
Acronym
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
April 17, 2023 (Actual)
Study Completion Date
April 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
Turku University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
Keywords
Chronic Subdural hematoma, Surgical evacuation, Recurrence, Irrigation fluid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, controlled, parallel group non-inferiority trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
587 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Irrigation group (IR)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No-Irrigation group (N-IR)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intraoperative irrigation
Intervention Description
Operation with irrigation
Intervention Type
Procedure
Intervention Name(s)
No irrigation
Intervention Description
Operation without irrigation
Primary Outcome Measure Information:
Title
Rate of re-operations of ipsilateral chronic subdural hematoma
Description
Rate of reoperations between groups
Time Frame
From operation up to 6 months after postoperatively
Secondary Outcome Measure Information:
Title
Change of Modified Rankin Scale (MRS) from baseline to 6 months after operation
Description
Modified Rankin scale ranges from 1 to 6, where 1 indicates normal daily functionality and 6 indicates death
Time Frame
At baseline, and at 2 and 6 months after operation
Title
Rate of mortality between intervention groups
Description
Rate of mortality between intervention groups
Time Frame
From operation up to 6 months postoperatively
Title
Duration of the operation between groups
Description
Time (minutes) used to complete the operation, from incision to last suture
Time Frame
Intraoperative measure
Title
Hospital length of stay between groups
Description
The duration of the stay in hospital (days)
Time Frame
From operation up to six months
Title
Change in the volume of CSDH in the CT or MRI image between baseline and 2 months post-operatively
Description
The volume of CSDH will be measured from preoperative CT or MRI and at 2 months after operation CT or MRI
Time Frame
Immediate preoperative and 2 months postoperatively
Title
Rate of complications and adverse events within 6 months
Description
Rate of complication rate between groups
Time Frame
within 6 months after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimmo Lönnrot, MD, Ph.D
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
32565480
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.
Results Reference
derived

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

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