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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2022
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Intervention

Procedure:
Irrigation fluid of body temperature
Irrigation fluid of body temperature will be used during burr hole evacuation of chronic subdural hematoma
Irrigation fluid of room temperature
Irrigation fluid of room temperature will be used during burr hole evacuation of chronic subdural hematoma.

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden Karolinska University Hospital, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

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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