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

May 18, 2024 updated by: Kimmo Lonnrot, Helsinki University Central Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
587

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of re-operations of ipsilateral chronic subdural hematoma
Time Frame: From operation up to 6 months after postoperatively
Rate of reoperations between groups
From operation up to 6 months after postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: From operation up to 6 months postoperatively
Rate of mortality between intervention groups
From operation up to 6 months postoperatively
Duration of the operation between groups
Time Frame: Intraoperative measure
Time (minutes) used to complete the operation, from incision to last suture
Intraoperative measure
Hospital length of stay between groups
Time Frame: From operation up to six months
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
Time Frame: 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
Immediate preoperative and 2 months postoperatively
Rate of complications and adverse events within 6 months
Time Frame: within 6 months after operation
Rate of complication rate between groups
within 6 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helsinki University Central Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Turku University Hospital
Oulu University Hospital
Kuopio University Hospital
Tampere University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kimmo Lönnrot, MD, Ph.D, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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