A study examining the effects of cooling the body after severe brain injury

Not Applicable

Completed

• Conditions: Traumatic brain injury complicated by increased intracranial pressure; Injury, Occupational Diseases, Poisoning; Intracranial injury

• Registration Number: ISRCTN34555414
• Lead Sponsor: niversity of Edinburgh and NHS Lothian (UK)

Brief Summary

2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21226939 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/24004918 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26444221 2018 results in http://www.ncbi.nlm.nih.gov/pubmed/30168413

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-30
• Study Completion: 2017-07-31
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Current inclusion criteria as of 14/08/2012:
1. Believed to be legal age for consent to take part in research, either sex
2. Primary closed traumatic brain injury
3. Raised ICP greater than 20 mmHg for greater than or equal to 5 minutes after first line treatments with no obvious reversible cause e.g. patient position, coughing, inadequate sedation
4. Less than or equal to 10 days from the initial head injury
5. Cooling device or technique available for greater than 48 hours
6. Core temperature greater than or equal to 36°C (at the time of randomisation)
7. An abnormal computed tomography (CT) scan of the brain. This is defined as one that shows haematoma, contusion, swelling, herniation or compressed basal cisterns.

Previous inclusion criteria as of 01/07/2009 and until 14/08/2012:
1. Believed to be legal age for consent to take part in research to 65 years of age, either sex
4. Less than or equal to 72 hours from the initial head injury

Initial information at time of registration (2008):
1. Adults aged 16 - 65 years, both males and females
2. Primary, closed traumatic brain injury
3. An abnormal computed tomography (CT) scan of brain, Marshall grade greater than 1
4. Refractory increased intracranial pressure (ICP) greater than 20 mmHg for at least 30 minutes (refractory to first line interventions including mechanical ventilation, sedation, analgesia ± muscle relaxant, head of bed elevation, with monitoring of CVP and invasive arterial pressure)
5. Core temperature greater than 36°C (at the time of randomisation)
6. Cooling device or technique available for greater than 48 hours

Exclusion Criteria

Current information as of 01/07/2009:
1. Patient already receiving therapeutic hypothermia treatment
2. Administration of barbiturate infusion prior to randomisation
3. Unlikely to survive for the next 24 hours in the opinion of the ICU Consultant or Consultant Neurosurgeon treating the patient
4. Temperature less than or equal to 34°C at hospital admission
5. Pregnancy

Initial information at time of registration:
1. Patients with bilateral fixed and dilated pupils
2. Unable to monitor ICP or patients with ICP less than 20 mmHg
3. Patients who have received barbiturates prior to randomisation
4. Where there is documented brainstem involvement
5. Moribund condition on admission

Study & Design

• Study Type: Interventional
• Study Design: Not specified