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

NCT02757235 | Completed DMC

• 1 other identifier: SIC01
• Study Type: interventional
• Target: 588
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Subdural Hematoma

Keywords

chronic subdural hematoma; irrigation; recurrence; burr hole evacuation; temperature

Outcome Measures

Primary Outcomes (1)

• Recurrence rate

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

  6 months

Secondary Outcomes (3)

• Mortality

  6 months

• Complications related to the surgery

  6 months

• Health related quality of life

  6 months

Study Arms (2)

Irrigation fluid of body temperature

ACTIVE COMPARATOR

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 room temperature

ACTIVE COMPARATOR

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

Interventions

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 body temperature

Irrigation fluid of room temperature PROCEDURE

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

Irrigation fluid of room temperature

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic subdural hematoma requiring burr hole evacuation.
• Patients older than 18 years of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Karolinska University Hospital: collaborator
• Uppsala University Hospital: collaborator

Study Sites (3)

Sahlgrenska Universtity Hospital, Department of neurosurgery, Sweden

Gothenburg, 41345, Sweden

Location

Karolinska University Hospital, Department of neurosurgery, Sweden

Solna, 17164, Sweden

Location

Uppsala University Hospital, Department of neurosurgery, Sweden

Uppsala, 75309, Sweden

Location

Related Publications (2)

• Bartley A, Bartek J Jr, Jakola AS, Sundblom J, Falt M, Forander P, Marklund N, Tisell M. Effect of Irrigation Fluid Temperature on Recurrence in the Evacuation of Chronic Subdural Hematoma: A Randomized Clinical Trial. JAMA Neurol. 2023 Jan 1;80(1):58-63. doi: 10.1001/jamaneurol.2022.4133.

  PMID: 36409480 DERIVED

• Bartley A, Jakola AS, Bartek J Jr, Sundblom J, Forander P, Marklund N, Tisell M. The Swedish study of Irrigation-fluid temperature in the evacuation of Chronic subdural hematoma (SIC!): study protocol for a multicenter randomized controlled trial. Trials. 2017 Oct 11;18(1):471. doi: 10.1186/s13063-017-2194-y.

  PMID: 29021000 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Recurrence

Condition Hierarchy (Ancestors)

Hematoma, Subdural; 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; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Magnus Tisell, MD, PhD

  Sahlgrenska Universtiy Hospital, Department of neurosurgery

  STUDY DIRECTOR

• Petter Förander, MD, PhD

  Karolinska University Hospital, Department of neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, neurosurgical resident

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 2, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 20, 2020
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

SE (3)