Chronic Subdural Hematoma
Conditions
Keywords
Chronic Subdural hematoma, Surgical evacuation, Recurrence, Irrigation fluid
Brief 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).
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.
Interventions
PROCEDUREIntraoperative irrigation
Operation with irrigation
PROCEDURENo irrigation
Operation without irrigation
Sponsors
Turku University Hospital
Oulu University Hospital
Tampere University Hospital
Kuopio University Hospital
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Due to the nature of the treatment, it is not possible to blind the surgeon and OR staff from the treatment allocation. Measures to minimize bias include: * The patient will not be informed of treatment allocation * Treatment allocation will not be documented in medical records i.e. all the personnel participating in patient care after operation will be blinded to allocation * The study group members collecting postoperative data and performing the statistical analyses will be blinded to treatment arm until the analyses are finished.
Intervention model description
Prospective, randomized, controlled, parallel group non-inferiority trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of re-operations of ipsilateral chronic subdural hematoma | From operation up to 6 months after postoperatively | Rate of reoperations between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of mortality between intervention groups | From operation up to 6 months postoperatively | Rate of mortality between intervention groups |
| Duration of the operation between groups | Intraoperative measure | Time (minutes) used to complete the operation, from incision to last suture |
| Change of Modified Rankin Scale (MRS) from baseline to 6 months after operation | 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 |
| Change in the volume of CSDH in the CT or MRI image between baseline and 2 months post-operatively | 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 |
| Rate of complications and adverse events within 6 months | within 6 months after operation | Rate of complication rate between groups |
| Hospital length of stay between groups | From operation up to six months | The duration of the stay in hospital (days) |
Countries
Finland
Outcome results
None listed