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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Subdural Hematoma

Intervention / Treatment
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* Procedure: Irrigation fluid of body temperature
* Procedure: Irrigation fluid of room temperature


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Irrigation fluid of body temperature<br>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<br>* Irrigation fluid of body temperature will be used during burr hole evacuation of chronic subdural hematoma<br>|
| Active Comparator: Irrigation fluid of room temperature<br>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<br>* Irrigation fluid of room temperature will be used during burr hole evacuation of chronic subdural hematoma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | Recurrences requiring repeat surgery during a 6-month follow up period | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | The proportion deceased at a given time during the 6 month follow up. | 6 months | 
| Complications related to the surgery | 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). | 6 months | 
| Health related quality of life | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic subdural hematoma, irrigation, recurrence, burr hole evacuation, temperature