Diagnostic performance of Baveno IV criteria in cirrhotic patients with upper gastrointestinal bleeding: analysis of the F7 liver-1288 study population

J Hepatol. 2010 Dec;53(6):1029-34. doi: 10.1016/j.jhep.2010.06.012. Epub 2010 Aug 12.

Abstract

Background & aims: The definition of failure to control bleeding agreed upon at the Baveno IV consensus meeting, included the Adjusted Blood Requirement Index [ABRI: number of blood units/(final-initial hematocrit+0.01)]. ABRI ≥0.75 denotes failure. However, timing for hematocrit measurements was not defined. The aims of this study were: (1) to assess the Baveno IV criteria performance to classify treatment success or failure to control bleeding at 5 days, (2) to determine the appropriate timing for hematocrit.

Methods: Two hundred and forty-two cirrhotic patients with gastrointestinal bleeding were independently classified by three clinical experts according to the Baveno IV criteria, by analysis of the database of a randomized trial. ABRI was calculated by using the closest hematocrit to the 5 day time point from the first trial product administration (ABRI-1) or after the latest transfusion within the 5-day period (ABRI-2). The gold standard for success/failure for 5-day control of bleeding was the clinical judgment of the three independent observers based on all the clinical and follow-up data.

Results: Inter-observer agreement for the final outcome assessment was 0.82 and a final consensus was obtained in 236/242 patients. Inter-observer agreement on patient classification with Baveno IV criteria was 0.70 with ABRI-1 and 0.84 with ABRI-2. c-statistics for correct patients classification were 0.86 for ABRI-1, 0.84 for ABRI-2, and 0.88 for Baveno IV criteria without ABRI. ABRI-1 caused misclassification of 27 patients and ABRI-2 of 39.

Conclusions: Baveno IV criteria are accurate to assess outcome of patients with variceal bleeding. There is a substantial observer variability linked to timing of hematocrits for ABRI calculation. With the current definition ABRI does not add to the performance of the other criteria.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Blood Transfusion
  • Esophageal and Gastric Varices / complications
  • Factor VIIa / therapeutic use
  • Female
  • Gastrointestinal Hemorrhage / blood
  • Gastrointestinal Hemorrhage / complications*
  • Gastrointestinal Hemorrhage / diagnosis*
  • Gastrointestinal Hemorrhage / therapy
  • Hematocrit
  • Humans
  • Hypertension, Portal / complications
  • Liver Cirrhosis / complications*
  • Male
  • Middle Aged
  • Recombinant Proteins / therapeutic use
  • Retrospective Studies
  • Time Factors
  • Treatment Failure
  • Treatment Outcome

Substances

  • Recombinant Proteins
  • recombinant FVIIa
  • Factor VIIa