The effect of transfusion on cerebral oxygenation in traumatic brain injury

ISRCTN	ISRCTN89085577
DOI	https://doi.org/10.1186/ISRCTN89085577
Protocol serial number	LREC 02/191
Sponsor	Cambridge University Hospitals NHS Foundation Trust (UK)
Funders	Association of Anaesthetists of Great Britain and Ireland (UK), Intensive Care Society (UK), Codman (Johnson & Johnson) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Arun Gupta
Scientific

Department of Anaesthesia
Box 93
Cambridge
CB2 2QQ
United Kingdom

Email	akg01@globalnet.co.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	The effect of transfusion on cerebral oxygenation in traumatic brain injury: a randomised controlled trial
Study objectives	Blood transfusion does not affect brain oxygenation in traumatic brain injury.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Traumatic brain injury
Intervention	Blood transfusion - the patients are randomised to 3 different transfusion triggers
Intervention type	Other
Primary outcome measure(s)	Brain tissue oxygen partial pressure.
Key secondary outcome measure(s)	1. Jugular venous saturation 2. Lactate/pyruvate ratio 3. Neurological outcome 4. Cerebral haemodynamics
Completion date	01/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	30
Key inclusion criteria	1. Greater than 16 years of age 2. Severe traumatic brain injury (i.e. traumatic brain injury resulting in a resuscitated Glasgow coma score of less than or equal to 8, resulting in intracranial hypertension (greater than 20 mmHg for greater than 10 minutes), or requiring neurosurgical intervention 3. Informed assent from the next of kin
Key exclusion criteria	1. Active haemorrhage 2. Active coronary ischaemia as judged by dynamic electrocardiogram (ECG) changes or positive troponin levels not due to myocardial contusion 3. Inability to place cerebral oxygenation monitors 4. Failure to fall below allocated transfusion threshold during intracranial pressure (ICP) monitoring
Date of first enrolment	01/07/2002
Date of final enrolment	01/12/2005

Department of Anaesthesia

Cambridge
CB2 2QQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2009		Yes	No