Clinical Trial: The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma - A Multicenter Randomised Controlled Trial

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.

Detailed Summary:
Sponsor: Sahlgrenska University Hospital, Sweden

Current Primary Outcome: Recurrence rate [ Time Frame: 6 months ]

Recurrences requiring repeat surgery during a 6-month follow up period


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mortality [ Time Frame: 6 months ]
    The proportion deceased at a given time during the 6 month follow up.
  • 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).
  • 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.


Original Secondary Outcome:

  • Mortality [ Time Frame: 6 months ]
    The proportion deceased at a given time during the 6 month follow up.
  • 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 ICU; Grade 3: invasive treatment required and ICU; Grade 4: death).
  • Health related quality of life [ Time Frame: 6 months ]
    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 By: Sahlgrenska University Hospital, Sweden

Dates:
Date Received: April 28, 2016
Date Started: March 2016
Date Completion: June 2018
Last Updated: June 15, 2016
Last Verified: May 2016