Chronic Subdural Hematoma Clinical Trial
— SIC!Official title:
The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma - A Multicenter Randomised Controlled Trial
NCT number | NCT02757235 |
Other study ID # | SIC01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | October 20, 2020 |
Verified date | February 2022 |
Source | Sahlgrenska University Hospital, Sweden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study will be a multicenter randomised controlled trial of the use of irrigation fluid of body temperature versus irrigation fluid of room temperature during burr hole evacuation of chronic subdural hematoma.
Status | Completed |
Enrollment | 588 |
Est. completion date | October 20, 2020 |
Est. primary completion date | October 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with chronic subdural hematoma requiring burr hole evacuation. - Patients older than 18 years of age. Exclusion Criteria: - Chronic subdural hematoma requiring surgical treatment other than burr hole evacuation. - Chronic subdural hematoma in a patient with an intracranial arachnoidal cyst. - Chronic subdural hematoma in a patient with a Cerebro Spinal Fluid-shunt. - Patients who have undergone intracranial surgery before. |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska Universtity Hospital, Department of neurosurgery, Sweden | Göteborg | |
Sweden | Karolinska University Hospital, Department of neurosurgery, Sweden | Solna | |
Sweden | Uppsala University Hospital, Department of neurosurgery, Sweden | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Sahlgrenska University Hospital, Sweden | Karolinska University Hospital, Uppsala University Hospital |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence rate | Recurrences requiring repeat surgery during a 6-month follow up period | 6 months | |
Secondary | Mortality | The proportion deceased at a given time during the 6 month follow up. | 6 months | |
Secondary | Complications related to the surgery | Complications will be assessed using the Landriel Ibanez classification modelThis model grades complications in 4 grades (Grade 1: no invasive treatment required; Grade 2: invasive treatment required, but not intensive care; Grade 3: invasive treatment required and intensive care; Grade 4: death). | 6 months | |
Secondary | Health related quality of life | A standardised instrument, EuroQoL 5D-3L, will be used as a generic measure of health related quality of life. The questionnaire contains 5 questions in different domains. | 6 months |
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