The Eurotherm3235trial will examine the relationship between ICP reduction after TBI using therapeutichypothermia and patient outcome.
ID
Source
Brief title
Condition
- Increased intracranial pressure and hydrocephalus
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
outcome at 6 months using the extended Glasgow Outcome Scale (GOSE)
questionnaire
Secondary outcome
6 month mortality rate, intracranial pressure control, incidence of pneumonia,
length of stay in hospital and ICU, Modified Oxford Handicap Scale score at one
month, discharge from randomising hospital or death whichever occurs first,
correlation betweenpredicted outcome using mOxford Handicap Scale at discharge
from hospital and the GOSE Score at 6 months and health economics
Background summary
Traumatic brain injury (TBI) is a major cause of death and severe disability
throughout the world. TBI leads
to 1,000,000 hospital admissions per annum throughout the European Union (EU).
Ischaemia has a key
role in all forms of brain injury and preventing ischaemic (or secondary)
injury is at the core of all treatment
strategies. The evidence from previous research shows that treatment with
therapeutic hypothermia to reduce
intracranial hypertension may improve patient outcome after TBI. Analysis has
shown key relationships
between length of hypothermia treatment and speed of re-warming with patient
outcome. Improved
patient outcome was found in the most recent meta-analysis when hypothermia was
continued for
between 48 hours and 5 days and patients were re-warmed slowly (1°C/4 hours).
Experience with
cooling also appears to be important if complications which may outweigh the
benefits of hypothermia are
to be avoided.
Study objective
The Eurotherm3235trial will examine the relationship between ICP reduction
after TBI using therapeutic
hypothermia and patient outcome.
Study design
Prospective randomised controlled trial without blinding
Intervention
Therapeutic hypothermia between 32 and 35 degrees Celsius to lower ICP to below
20 mmHg
Study burden and risks
Potential adverse events of therapeutic hypothermia are well known, but on the
other hand experience with this treatment at our ICU is extensive because this
treatment is routinely applied at a very regular basis in every post cardiac
arrest comatose patient. We monitor specific adverse events in the treatment
group and a monitoring plan is available. This study is done because there may
well be a beneficial effect overall on secondary brain injury with regard to
functional outcome as well as mortality. Therefore we think that the benefits
of therapeutic hypothermia may outweigh the adverse events.
's-Gravendijkwal 230
3015CE Rotterdam
NL
's-Gravendijkwal 230
3015CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
1.18 years of age or older 2.primary closed traumatic brain injury 3.raised ICP>20mmHg 4. up to 10 days after initial head injury 5.cooling device or technique available for at least 48 hours 6.core temperature 36 degrees Celsius or higher at the time of randomisation 7.abnormal CT of the brain
Exclusion criteria
1.already receiving therapeutic hypothermia 2.barbiturate therapy prior to inclusion 3.unlikely to survive in next 24 hours according to ICU consultant or neurosurgeon 4.temperature 34 degrees or less at admission 5.pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 34555414 |
| CCMO | NL35865.078.11 |