Blood Journal
Leading the way in experimental and clinical research in hematology

Standardization of bleeding assessment in immune thrombocytopenia: report from the International Working Group

  1. Francesco Rodeghiero1,*,
  2. Marc Michel2,
  3. Terry Gernsheimer3,
  4. Marco Ruggeri1,
  5. Victor Blanchette4,
  6. James B. Bussel5,
  7. Douglas B. Cines6,
  8. Nichola Cooper7,
  9. Bertrand Godeau2,
  10. Andreas Greinacher8,
  11. Paul Imbach9,
  12. Mehdi Khellaf2,
  13. Robert J. Klaassen10,
  14. Thomas Kühne9,
  15. Howard Liebman11,
  16. Maria Gabriella Mazzucconi12,
  17. Adrian Newland13,
  18. Ingrid Pabinger14,
  19. Alberto Tosetto1, and
  20. Roberto Stasi15
  1. 1 Department of Cell Therapy and Hematology, San Bortolo Hospital, Vicenza, Italy;
  2. 2 Universite Paris-Est Creteil, Assistance Publique hopitaux de Paris, Hopital Henri Mondor, Department of Internal Medicine, Creteil, France;
  3. 3 Puget Sound Blood Center, University of Washington School of Medicine, Washington, WA, United States;
  4. 4 Division of Hematology/Oncology, The Hospital for Sick Children, Department of Pediatrics, University of Toronto, Toronto, ON, Canada;
  5. 5 Division of Pediatric Hematology/Oncology, Weill Medical College of Cornell University, New York, NY, United States;
  6. 6 Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States;
  7. 7 Department of Hematology, Imperial College NHS Trust, Hammersmith Hospital, London, United Kingdom;
  8. 8 Department of Immunology and Transfusion Medicine, Ernst-Moritz-Arndt-University, Greifswald, Germany;
  9. 9 University Children's Hospital Basel, Pediatric Oncology/Hematology, Basel, Switzerland;
  10. 10 Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, ON, Canada;
  11. 11 Jane Anne Nohl Division of Hematology and Center for the Study of Blood Diseases, Los Angeles, CA, United States;
  12. 12 Department of Cellular Biotechnology and Hematology, La Sapienza University, Roma, Italy;
  13. 13 Pathology Clinical Academic Unit - Barts and the London NHS Trust, London, United Kingdom;
  14. 14 Division of Haematology and Haemostaseology, Department of Medicine I, Medical University, Vienna, Austria;
  15. 15 Department of Haematology, St. George's Hospital NHS Trust, London, United Kingdom
  1. * Corresponding author; email: rodeghiero{at}


In a previous publication on new terminology, definitions and outcome criteria for immune thrombocytopenia (ITP), the International Working Group (IWG) on ITP acknowledged that response to treatment should consist of clinically meaningful endpoints, like bleeding manifestations, and that platelet count may not be the ideal parameter to capture the benefits of therapy. The IWG now proposes a consensus based ITP-specific bleeding assessment tool (ITP-BAT) with definitions and terminology consistent with those adopted for other bleeding disorders. Bleeding manifestations were grouped into three major domains: Skin (S), visible Mucosae (M) and Organs (O) with Gradation of severity (SMOG). Each bleeding manifestation is assessed at the time of examination. Severity is graded from 0 to 3 or 4, with grade 5 for any fatal bleeding. Bleeding reported by the patient without medical documentation is graded 1. Within each domain, the same grade is assigned to bleeding manifestations of similar clinical impact. The "worst bleeding manifestation since the last visit" (observation period) is graded (a suitable data-base collection form is provided). Then, the highest grade within each domain is recorded. The SMOG system provides a consistent description of the bleeding phenotype in ITP and the IWG unanimously supports its adoption and validation in future clinical studies.

  • Submitted July 15, 2012.
  • Accepted January 12, 2013.