Contact information
Type
Scientific
Primary contact
Prof Arun Gupta
ORCID ID
Contact details
Department of Anaesthesia
Box 93
Cambridge
CB2 2QQ
United Kingdom
akg01@globalnet.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LREC 02/191
Study information
Scientific title
The effect of transfusion on cerebral oxygenation in traumatic brain injury: a randomised controlled trial
Acronym
Study hypothesis
Blood transfusion does not affect brain oxygenation in traumatic brain injury.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Traumatic brain injury
Intervention
Blood transfusion - the patients are randomised to 3 different transfusion triggers
Intervention type
Other
Phase
Not Applicable
Drug names
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 trial start date
01/07/2002
Overall trial end date
01/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant 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
Recruitment start date
01/07/2002
Recruitment end date
01/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthesia
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Cambridge University Hospitals NHS Foundation Trust (UK)
Sponsor details
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
jn254@cam.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
Association of Anaesthetists of Great Britain and Ireland (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Intensive Care Society (UK)
Alternative name(s)
ICS
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
Location
United Kingdom
Funder name
Codman (Johnson & Johnson) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19237920
Publication citations
-
Results
Zygun DA, Nortje J, Hutchinson PJ, Timofeev I, Menon DK, Gupta AK, The effect of red blood cell transfusion on cerebral oxygenation and metabolism after severe traumatic brain injury., Crit. Care Med., 2009, 37, 3, 1074-1078, doi: 10.1097/CCM.0b013e318194ad22.