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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 March 2022 |
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Main ID: |
NCT02757235 |
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Date of registration:
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28/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma
SIC! |
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Scientific title:
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The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma - A Multicenter Randomised Controlled Trial |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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588 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02757235 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Asgeir Jakola, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sahlgrenska University Hospital, Department of neurosurgery |
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Name:
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Magnus Tisell, MD, PhD |
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Address:
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Email:
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Affiliation:
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Sahlgrenska Universtiy Hospital, Department of neurosurgery |
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Name:
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Jiri Bartek, MD |
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Address:
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Email:
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Affiliation:
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Karolinska University Hospital, Department of neurosurgery |
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Name:
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Niklas Marklund, MD, Phd |
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Address:
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Email:
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Affiliation:
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Akademiska University Hospital, Department of neurosurgery |
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Name:
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Andreas Bartley, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sahlgrenska University Hospital, Department of neurosurgery |
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Name:
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Jimmy Sundblom, MD, Phd |
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Address:
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Telephone:
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Email:
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Affiliation:
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Akademiska University Hospital, Department of neurosurgery |
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Name:
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Petter Förander, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Karolinska University Hospital, Department of neurosurgery |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Subdural Hematoma
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Intervention(s)
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Procedure: Irrigation fluid of body temperature
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Procedure: Irrigation fluid of room temperature
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Primary Outcome(s)
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Recurrence rate
[Time Frame: 6 months]
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Secondary Outcome(s)
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Complications related to the surgery
[Time Frame: 6 months]
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Health related quality of life
[Time Frame: 6 months]
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Mortality
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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