TRIGGER: Transfusion In Gastrointestinal Bleeding
A multi-centre, feasibility, cluster randomised controlled trial comparing restrictive versus liberal blood transfusion strategies in adult patients with acute upper gastrointestinal bleeding
|Funding:||NHS Blood and Transplant (NHSBT)|
|Collaborators:||Professor Mike Murphy, NHSBT Oxford Centre|
|Information:||Helen Campbell, Liz Stokes|
Acute upper gastrointestinal bleeding (AUGIB) is the most common reason for emergency hospital admission with a gastrointestinal disorder in the UK, and is also a leading consumer of red blood cells (RBCs). RBCs are transfused because the haemoglobin concentration has fallen below a threshold at which the clinician believes the benefits of transfusion outweigh the risks. Since the indications for transfusion in AUGIB are not clearly defined, this threshold is subjective and varies between clinicians and hospitals. This RCT will evaluate the feasibility and safety of implementing a restrictive versus liberal RBC transfusion policy in adult patients admitted with AUGIB in order to inform the design of a definitive phase III RCT. The study will take place in six UK hospitals and they will be randomised to a transfusion policy at the cluster level; three sites will be randomised to a restrictive transfusion policy and three to a liberal transfusion policy. This trial will determine whether sufficient numbers of patients can be recruited, and whether clinicians can adhere to their allocated transfusion policy, in order to justify an application for a phase III trial. Feasibility and clinical outcomes, and health-related quality of life will be collected. Further information on the trial can be found at http://www.nhsbt.nhs.uk/clinicaltrialsunit/current-trials/trigger
Health economics will be incorporated in to the trial in two ways. Firstly, the feasibility of gathering data required to facilitate a cost-effectiveness analysis (e.g. resource use, costs, outcomes) will be examined to inform data collection for the phase III trial. Secondly, the feasibility of using these data within a cost-effectiveness model will be explored to identify parameters with the potential to be key drivers of cost-effectiveness, and hence requiring detailed measurement in the phase III trial.