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PTU-184 Restrictive Versus Liberal Blood Transfusion For Acute Upper Gastrointestinal Bleeding: Cluster Randomised Feasibility Trial
  1. V Jairath1,
  2. B Kahan2,
  3. A Gray3,
  4. C Dore2,
  5. K Palmer4,
  6. S Travis1,
  7. R Logan5,
  8. T Walsh3,
  9. M Murphy6
  10. on behalf of TRIGGER Investigators
  1. 1Translational Gastroenterology Unit, Oxford, UK
  2. 2MRC CTU, London, UK
  3. 3University of Edinburgh, UK
  4. 4Western General Infirmary, Edinburgh, UK
  5. 5University of Nottingham, Nottingham, UK
  6. 6NHSBT, Oxford, UK

Abstract

Introduction Transfusion thresholds for upper gastrointestinal bleeding (UGIB) are controversial. Observational studies suggest associations between liberal red blood cell (RBC) transfusion and adverse outcome, and a recent trial reported increased mortality following liberal transfusion.

Methods Pragmatic cluster randomised trial to evaluate the feasibility and safety of implementing a restrictive (transfusion when haemoglobin (Hb) <8g dL) versus liberal (transfusion when Hb <10 g/dL) RBC transfusion policy for UGIB. Hospitals were randomised to a policy which was implemented through a multi-faceted educational intervention targeting all staff caring for patients with UGIB. All adult patients were eligible to participate, regardless of co-morbidity; the only exclusion criterion was exsanguinating haemorrhage. Feasibility and exploratory clinical outcomes were recorded up to day 28.

Results 936 patients were enrolled in 6 hospitals. The consent rate for follow up was higher in the liberal arm (62% vs. 55%; P = 0.04). There were some baseline imbalances, however the Rockall and Blatchford scores were identical between arms as was the prevalence of ischaemic heart disease (IHD) (14% liberal arm vs. 15% restrictive arm). Protocol adherence was 96% in the restrictive arm vs. 83% in the liberal arm. In patients with a Hb <12 g/dL, the Hb at discharge was 10.7 g/dL (sd 1.2) in the liberal arm vs. 10.1 g/dL (sd 1.3) in the restrictive arm (P = 0.05). In the restrictive arm there was a 13% absolute reduction in the proportion of patients receiving RBCs (95% CI for difference in% -35 to 11, P = 0.23) with a mean of 0.8 fewer RBC units transfused (95% CI: -1.9 –to 0.3, P = 0.12). Clinical outcomes were better in the restrictive arm, although differences were not statistically significant (28-day mortality, 7% liberal vs. 5% restrictive, adjusted difference in% = -1.3, 95% CI: -8.0 to 5.5, P = 0.63; further bleeding, 9 vs. 5%, P = 0.29; serious adverse events, 22% vs. 18%, P = 0.48). In the subgroup with IHD, there was a large observed difference for mortality (12% restrictive arm (n = 6) vs. 3% liberal arm (n = 2); interaction P = 0.11).

Conclusion The protocol was feasible and generated clinically important differences in the level of anaemia and RBC exposure. There was a consistent trend towards fewer complications in the restrictive arm, apart from the increased mortality observed in patients with IHD, which could in part be explained by imbalances in baseline risk. A large trial is required to clarify the risk-benefit balance before advocating restrictive RBC transfusion for all patients with UGIB.

Disclosure of Interest None Declared.

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