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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Subdural Hematoma

Intervention / Treatment
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* Procedure: Intraoperative irrigation
* Procedure: No irrigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, controlled, parallel group non-inferiority trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Irrigation group (IR)<br>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<br>* Operation with irrigation<br>|
| Experimental: No-Irrigation group (N-IR)<br>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<br>* Operation without irrigation<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Subdural hematoma, Surgical evacuation, Recurrence, Irrigation fluid