An interventional study of Intraoperative irrigation and No irrigation in Chronic Subdural Hematoma, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
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).
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.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's enrollment of 587 is above the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
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Patients with a symptomatic unilateral or bilateral CSDH requiring burr-hole evacuation
o Predominantly hypodense or isodense on imaging (CT/MRI).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Operation with irrigation
Operation without irrigation
Rate of re-operations of ipsilateral chronic subdural hematoma
Rate of reoperations between groups
Time frame: From operation up to 6 months after postoperatively
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
Time frame: At baseline, and at 2 and 6 months after operation
Rate of mortality between intervention groups
Rate of mortality between intervention groups
Time frame: 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
Time frame: Intraoperative measure
Hospital length of stay between groups
The duration of the stay in hospital (days)
Time frame: 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
Time frame: Immediate preoperative and 2 months postoperatively
Rate of complications and adverse events within 6 months
Rate of complication rate between groups
Time frame: within 6 months after operation
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data (IPD) is available upon request when General Data Protection Regulation (GDPR) and guiding legislation regulations are fulfilled.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Study protocol and Statistical Analysis Plan (SAP) will be published after the study has started. Other document will be available as study proceeds and after study is completed.
Access criteria: Data access request will be reviewed by FINISH-trial steering group. Requestors will be required to sign a Data Access Agreement.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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