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

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Chronic Subdural Hematoma

Treatments: Procedure: No irrigation; Procedure: Intraoperative irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT04203550

3035/2019

Details and patient eligibility

About

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).

Full 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.

Enrollment: 587 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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587 participants in 2 patient groups

Irrigation group (IR)

Active Comparator group

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.

Treatment:

Procedure: Intraoperative irrigation

No-Irrigation group (N-IR)

Experimental group

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.

Treatment:

Procedure: No irrigation