The effect of transfusion on cerebral oxygenation in traumatic brain injury

ISRCTN	ISRCTN89085577
DOI	https://doi.org/10.1186/ISRCTN89085577
Secondary identifying numbers	LREC 02/191

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	Brain tissue oxygen partial pressure.
Secondary outcome measures	1. Jugular venous saturation 2. Lactate/pyruvate ratio 3. Neurological outcome 4. Cerebral haemodynamics
Overall study start date	01/07/2002
Completion date	01/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
England
United Kingdom

Research organisation

Association of Anaesthetists of Great Britain and Ireland (UK)

No information available

Intensive Care Society (UK)
Private sector organisation / Associations and societies (private and public)

Codman (Johnson & Johnson) (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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