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The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma (SIC!)

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ClinicalTrials.gov Identifier: NCT02757235
Recruitment Status : Recruiting
First Posted : May 2, 2016
Last Update Posted : April 4, 2019
Sponsor:
Collaborators:
Karolinska University Hospital
Uppsala University Hospital
Information provided by (Responsible Party):
Andreas Bartley, Sahlgrenska University Hospital, Sweden

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Subdural Hematoma Procedure: Irrigation fluid of body temperature Procedure: Irrigation fluid of room temperature Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma - A Multicenter Randomised Controlled Trial
Study Start Date : March 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Active Comparator: Irrigation fluid of body temperature
During burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of body temperature (approximately 37 degrees Celsius)
Procedure: Irrigation fluid of body temperature
Irrigation fluid of body temperature will be used during burr hole evacuation of chronic subdural hematoma

Active Comparator: Irrigation fluid of room temperature
During burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of room temperature (approximately 22 degrees Celsius)
Procedure: Irrigation fluid of room temperature
Irrigation fluid of room temperature will be used during burr hole evacuation of chronic subdural hematoma.




Primary Outcome Measures :
  1. Recurrence rate [ Time Frame: 6 months ]
    Recurrences requiring repeat surgery during a 6-month follow up period


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 6 months ]
    The proportion deceased at a given time during the 6 month follow up.

  2. Complications related to the surgery [ Time Frame: 6 months ]
    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).

  3. Health related quality of life [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757235


Contacts
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Contact: Andreas Bartley, MD 313429625 ext +46 andreas.bartley@vgregion.se
Contact: Magnus Tisell, MD, PhD 313421000 ext +46 magnus.tisell@vgregion.se

Locations
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Sweden
Sahlgrenska Universtity Hospital, Department of neurosurgery, Sweden Recruiting
Göteborg, Sweden, 41345
Contact: Andreas Bartley, MD    313429625 ext +46    andreas.bartley@vgregion.se   
Contact: Magnus Tisell, MD, PhD    313421000 ext +46    magnus.tisell@vgregion.se   
Principal Investigator: Asgeir Jakola, MD, PhD         
Karolinska University Hospital, Department of neurosurgery, Sweden Recruiting
Solna, Sweden, 17164
Contact: Jiri Bartek, MD    08517 700 00 ext +46    jiri.bartek@karolinska.se   
Principal Investigator: Petter Förander, MD, PhD         
Uppsala University Hospital, Department of neurosurgery, Sweden Recruiting
Uppsala, Sweden, 75309
Contact: Jimmy Sundblom, MD, PhD    18611 00 00 ext +46    jimmy.sundblom@neuro.uu.se   
Contact: Niklas Marklund, MD, PhD    18611 00 00 ext +46    niklas.marklund@akademiska.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Karolinska University Hospital
Uppsala University Hospital
Investigators
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Principal Investigator: Asgeir Jakola, MD, PhD Sahlgrenska University Hospital, Department of neurosurgery
Principal Investigator: Niklas Marklund, MD, Phd Akademiska University Hospital, Department of neurosurgery
Principal Investigator: Jimmy Sundblom, MD, Phd Akademiska University Hospital, Department of neurosurgery
Principal Investigator: Jiri Bartek, MD Karolinska University Hospital, Department of neurosurgery
Principal Investigator: Andreas Bartley, MD Sahlgrenska University Hospital, Department of neurosurgery
Study Director: Magnus Tisell, MD, PhD Sahlgrenska Universtiy Hospital, Department of neurosurgery
Principal Investigator: Petter Förander, MD, PhD Karolinska University Hospital, Department of neurosurgery
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andreas Bartley, MD, neurosurgical resident, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02757235    
Other Study ID Numbers: SIC01
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Andreas Bartley, Sahlgrenska University Hospital, Sweden:
chronic subdural hematoma
irrigation
recurrence
burr hole evacuation
temperature
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
Hematoma
Hemorrhage
Pathologic Processes
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries