Traumatic brain injury complicated by increased intracranial pressure Injury, Occupational Diseases, Poisoning Intracranial injury
Conditions
Interventions
Current information as of 01/07/2009:
Intervention Group: Usual traumatic brain injury management with therapeutic hypothermia (32 - 35°C) for at least 48 hours. The depth of hypothermia will be depen
Sponsors
University of Edinburgh and NHS Lothian (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome at 6 months using the extended Glasgow Outcome Score (GOSE) questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Current information as of 01/07/2009: 1. 6-month mortality rate 2. Intracranial pressure (ICP) control 3. Incidence of Pneumonia across both groups 4. Length of stay in the Intensive Care Unit (ICU) and Hospital 5. Modified Oxford Handicap Scale score at one month, discharge from the randomising hospital or death, whichever occurs first 6. Correlation between the predicted outcome using the modified Oxford handicap scale at hospital discharge and the GOSE Score at 6 months post injury 7. Health economics (dependent on additional external funding) Other planned analyses: A priori sub group analysis will be presented testing the relationship between minimisation factors including; age 20 mmHg and duration ICP >20 mmHg 2. Length of intensive care unit (ICU) and hospital stay 3. Head Injury Related Early Outcome Scale (HIREOS) at 21 days 4. Mortality Other planned analyses: A priori sub group analysis will be testing the relationship between minimisation factors, including age less than and age older than 45 years, presence of cerebral contusion on CT scanning, admission post resuscitation GCS <5, gender, cooling technology, and outcome. Stricter levels of statistical significance (p <0.01) will be sought, reflecting the exploratory nature of these subgroup analyses. Primary outcome measure only will be used in these analyses. Other exploratory, observational studies will be conducted by some centres and will include assessment of the genetics of responsiveness to hypothermia (to be lead by Professor Menon), modulation of inflammation (including response to intercurrent infection) and effect upon cerebral vascular autoregulation. There are likely to be other sub-studies run by centre PIs and all will require approval by the steering committee and will have identified external funding. | — |
Countries
Belgium, Estonia, Germany, Greece, Hungary, India, Ireland, Italy, Netherlands, Portugal, Russian Federation, Saudi Arabia, Spain, United Arab Emirates, United Kingdom
Outcome results
None listed