The Finnish Study of Intraoperative Irrigation Versus Drain Alone After Evacuation of Chronic Subdural Hematoma (FINISH) (FINISH)
Chronic Subdural Hematoma
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
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
Active Comparator
Experimental
Irrigation group (IR)
No-Irrigation group (N-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.
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.