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Updated: Jun 1, 2026

Microfluidics in Assessing Platelet Function
06:47

Microfluidics in Assessing Platelet Function

Published on: November 8, 2024

Adjudicating bleeding events in a platelet dose study: impact on outcome results and challenges

Nancy M Heddle1, Cynthia Wu, Ralph Vassallo

  • 1Department of Medicine, McMaster University, Hamilton, Ontario, Canada. heddlen@mcmaster.ca

Transfusion
|May 24, 2011
PubMed

Insights

Adjudicating bleeding events using the World Health Organization (WHO) criteria showed significant disagreement, especially with fewer adjudicators. This impacts the reported frequency of bleeding in clinical studies.

Area of Science:

  • Hematology
  • Clinical Trials
  • Medical Research

Background:

  • The SToP platelet dose study utilized adjudication for assigning World Health Organization (WHO) bleeding grades.
  • Challenges in bleeding event adjudication and comparison of adjudicated versus bedside grading were investigated.

Purpose of the Study:

  • To describe challenges in adjudicating bleeding events.
  • To compare adjudicated bleeding grades with bedside assessments.

Main Methods:

  • Daily bleeding assessments, interventions, blood counts, and transfused components were provided to adjudicators.
  • Two adjudicators independently assigned bleeding grade and site; disagreements were resolved by consensus among up to five adjudicators.
  • Adjudicated grades were compared with bedside grades assigned by study personnel.

Main Results:

  • Disagreement on bleeding grade was frequent, decreasing with more adjudicators (31.2% with two, 0.05% with five).
  • Anatomic site disagreement occurred in 17% of cases after two adjudicators.
  • Adjudication resulted in a higher frequency of bleeding (≥ Grade 2) compared to bedside grading.

Conclusions:

  • The reported frequency of WHO bleeding is method-dependent.
  • Adjudication for bleeding grade assignment led to substantial disagreement when only two adjudicators were involved.
Abstract

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