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
Scientific
Department of Anaesthesia
Box 93
Cambridge
CB2 2QQ
United Kingdom
akg01@globalnet.co.uk |
Study information
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 |
Eligibility
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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Anaesthesia
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
England
United Kingdom
jn254@cam.ac.uk | |
Website | http://www.cuh.org.uk/ |
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)
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 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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/03/2009 | Yes | No |