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
Submission date
08/09/2005
Registration date
06/10/2005
Last edited
03/03/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Arun Gupta
Scientific

Department of Anaesthesia
Box 93
Cambridge
CB2 2QQ
United Kingdom

Email akg01@globalnet.co.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe effect of transfusion on cerebral oxygenation in traumatic brain injury: a randomised controlled trial
Study objectivesBlood 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) studiedTraumatic brain injury
InterventionBlood transfusion - the patients are randomised to 3 different transfusion triggers
Intervention typeOther
Primary outcome measureBrain tissue oxygen partial pressure.
Secondary outcome measures1. Jugular venous saturation
2. Lactate/pyruvate ratio
3. Neurological outcome
4. Cerebral haemodynamics
Overall study start date01/07/2002
Completion date01/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants30
Key inclusion criteria1. 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 criteria1. 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 enrolment01/07/2002
Date of final enrolment01/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Anaesthesia
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

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

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

Email jn254@cam.ac.uk
Website http://www.cuh.org.uk/
ROR logo "ROR" https://ror.org/04v54gj93

Funders

Funder type

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)
Alternative name(s)
ICS
Location
United Kingdom
Codman (Johnson & Johnson) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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