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

Chronic Subdural Hematoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203550
• Other study ID #: 3035/2019
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: February 14, 2023

Study information

• Verified date: May 2024
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 587
• Est. completion date: February 14, 2023
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Procedure:
• Intraoperative irrigation
Operation with irrigation
• No irrigation
Operation without irrigation

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki

Sponsors (5)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Kuopio University Hospital, Oulu University Hospital, Tampere University Hospital, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of re-operations of ipsilateral chronic subdural hematoma	Rate of reoperations between groups	From operation up to 6 months after postoperatively
Secondary	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
Secondary	Rate of mortality between intervention groups	Rate of mortality between intervention groups	From operation up to 6 months postoperatively
Secondary	Duration of the operation between groups	Time (minutes) used to complete the operation, from incision to last suture	Intraoperative measure
Secondary	Hospital length of stay between groups	The duration of the stay in hospital (days)	From operation up to six months
Secondary	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
Secondary	Rate of complications and adverse events within 6 months	Rate of complication rate between groups	within 6 months after operation