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The effect of transfusion on cerebral oxygenation in traumatic brain injury
ISRCTN ISRCTN89085577
DOI 10.1186/ISRCTN89085577
ClinicalTrials.gov identifier
EudraCT number
Public title The effect of transfusion on cerebral oxygenation in traumatic brain injury
Scientific title The effect of transfusion on cerebral oxygenation in traumatic brain injury: a randomised controlled trial
Acronym N/A
Serial number at source LREC 02/191
Study hypothesis Blood transfusion does not affect brain oxygenation in traumatic brain injury.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Traumatic brain injury
Participants - 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
Participants - 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
Anticipated start date 01/07/2002
Anticipated end date 01/12/2005
Status of trial Completed
Patient information material
Target number of participants 30
Interventions Blood transfusion - the patients are randomised to 3 different transfusion triggers
Primary outcome measure(s) Brain tissue oxygen partial pressure.
Secondary outcome measure(s) 1. Jugular venous saturation
2. Lactate/pyruvate ratio
3. Neurological outcome
4. Cerebral haemodynamics
Sources of funding 1. Association of Anaesthetists of Great Britain and Ireland (UK)
2. Intensive Care Society (UK)
3. Codman (Johnson & Johnson) (UK)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19237920
Contact name Prof  Arun  Gupta
  Address Department of Anaesthesia
Box 93
  City/town Cambridge
  Zip/Postcode CB2 2QQ
  Country United Kingdom
  Email akg01@globalnet.co.uk
Sponsor Cambridge University Hospitals NHS Foundation Trust (UK)
  Address Addenbrooke's Hospital
Hills Road
  City/town Cambridge
  Zip/Postcode CB2 2QQ
  Country United Kingdom
  Email jn254@cam.ac.uk
  Sponsor website: http://www.cuh.org.uk/
Date applied 08/09/2005
Last edited 03/03/2009
Date ISRCTN assigned 06/10/2005
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