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NCT Number: NCT02757235

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

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.

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Key information

Conditions

Chronic Subdural Hematoma Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Craniocerebral Trauma Disease Attributes Hematoma Hematoma, Subdural Hematoma, Subdural, Chronic Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska Universtity Hospital, Department of neurosurgery, Sweden, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Irrigation fluid of body temperature

Procedure

Irrigation fluid of body temperature will be used during burr hole evacuation of chronic subdural hematoma

Irrigation fluid of room temperature

Procedure

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

Primary outcomes

  1. Recurrence rate

    Time frame: 6 months

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Karolinska University Hospital
  • Uppsala University Hospital

Registry information

Official study title

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

Acronym: SIC!

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 2, 2016
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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