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The Swedish study of Irrigation-fluid temperature in the evacuation of Chronic subdural hematoma (SIC!): study protocol for a multicenter randomized controlled trial
Sahlgrens Univ Hosp, Dept Neurosurg, Bla Straket 5, S-41345 Gothenburg, Sweden.;Univ Gothenburg, Sahlgrenska Acad, Dept Clin Neurosci, Inst Neurosci & Physiol, Box 430, S-40530 Gothenburg, Sweden..
Sahlgrens Univ Hosp, Dept Neurosurg, Bla Straket 5, S-41345 Gothenburg, Sweden.;Univ Gothenburg, Sahlgrenska Acad, Dept Clin Neurosci, Inst Neurosci & Physiol, Box 430, S-40530 Gothenburg, Sweden.;St Olavs Hosp, Dept Neurosurg, N-7006 Trondheim, Norway..
Karolinska Univ Hosp, Dept Neurosurg, Solna, Sweden.;Karolinska Inst, Sect Neurosurg, Dept Clin Neurosci, Stockholm, Sweden.;Rigshosp, Dept Neurosurg, Copenhagen Univ Hosp, Copenhagen, Denmark..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Neurosurgery.
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2017 (English)In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 18, article id 471Article in journal (Refereed) Published
Abstract [en]

Background: Chronic subdural hematoma (cSDH) is one of the most common conditions encountered in neurosurgical practice. Recurrence, observed in 5-30% of patients, is a major clinical problem. The temperature of the irrigation fluid used during evacuation of the hematoma might theoretically influence recurrence rates since irrigation fluid at body temperature (37 degrees C) may beneficially influence coagulation and cSDH solubility when compared to irrigation fluid at room temperature. Should no difference in recurrence rates be observed when comparing irrigation-fluid temperatures, there is no need for warmed fluids during surgery. Our main aim is to investigate the effect of irrigation-fluid temperature on recurrence rates and clinical outcomes after cSDH evacuation using a multicenter randomized controlled trial design.

Methods: The study will be conducted in three neurosurgical departments with population-based catchment areas using a similar surgical strategy. In total, 600 patients fulfilling the inclusion criteria will randomly be assigned to either intraoperative irrigation with fluid at body temperature or room temperature. The power calculation is based on a retrospective study performed at our department showing a recurrence rate of 5% versus 12% when comparing irrigation fluid at body temperature versus fluid at room temperature (unpublished data). The primary endpoint is recurrence rate of cSDH analyzed at 6 months post treatment. Secondary endpoints are mortality rate, complications and health-related quality of life.

Discussion: Irrigation-fluid temperature might influence recurrence rates in the evacuation of chronic subdural hematomas. We present a study protocol for a multicenter randomized controlled trial investigating our hypothesis that irrigation fluid at body temperature is superior to room temperature in reducing recurrence rates following evacuation of cSDH.

Place, publisher, year, edition, pages
BIOMED CENTRAL LTD , 2017. Vol. 18, article id 471
Keyword [en]
Chronic subdural hematoma, Surgical evacuation, Recurrence, Irrigation fluid, Temperature
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:uu:diva-338514DOI: 10.1186/s13063-017-2194-yISI: 000412904300001PubMedID: 29021000OAI: oai:DiVA.org:uu-338514DiVA, id: diva2:1174002
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Region Västra Götaland
Available from: 2018-01-15 Created: 2018-01-15 Last updated: 2018-01-15Bibliographically approved

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