Condition category
Injury, Occupational Diseases, Poisoning
Date applied
08/09/2005
Date assigned
06/10/2005
Last edited
03/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.cuh.org.uk/

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

professional associations and societies

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19237920

Publication citations

  1. 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.

Additional files

Editorial Notes