Do all patients with hematologic malignancies and severe thrombocytopenia need prophylactic platelet transfusions? Background, rationale, and design of a clinical trial (trial of platelet prophylaxis) to assess the effectiveness of prophylactic platelet transfusions.

Transfusion Medicine Reviews
Simon J StanworthTOPPS Study Group

Abstract

Although considerable advances have been made in many aspects of platelet transfusion therapy in the last 30 years, some areas continue to provoke debate, including the use of prophylactic platelet transfusions for the prevention of thrombocytopenic bleeding in patients with bone marrow failure. We have designed a randomized controlled trial to compare prophylactic platelet use with a threshold of a platelet count of 10 x 10(9)/L with no prophylaxis in adult thrombocytopenic patients with hematologic malignancies. The trial question is whether a no-prophylactic policy for the use of platelet transfusions in patients with hematologic malignancies is not inferior to a threshold prophylactic policy at 10 x 10(9)/L, for bleeding at World Health Organization (WHO) grade 2, 3, or 4, up to 30 days from randomization. The primary outcome measure is the proportion of patients who have a significant clinical bleed, defined as WHO grade 2 or higher up to 30 days from randomization. Subsidiary clinical outcome measures include time to first bleed and a descriptive analysis of all severe bleeds. A bleeding assessment form is completed daily for all study subjects until day 30 from randomization. Minor modifications were made to the definiti...Continue Reading

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Citations

Sep 29, 2011·British Journal of Haematology·Subarna Chakravorty, Irene Roberts
May 28, 2011·British Journal of Haematology·Lise J EstcourtM F Murphy
Jul 8, 2011·Transfusion Medicine·C E Butler, E L Dickens
Oct 21, 2016·American Journal of Hematology·Nabin KhanalVijaya R Bhatt
Jul 5, 2011·Transfusion clinique et biologique : journal de la Société française de transfusion sanguine·G Andreu
May 10, 2013·The New England Journal of Medicine·Simon J StanworthUNKNOWN TOPPS Investigators
Sep 29, 2011·Current Opinion in Hematology·Sherrill J Slichter
Jan 12, 2013·Transfusion·Lise J EstcourtUNKNOWN Biomedical Excellence for Safer Transfusion Collaborative
May 16, 2014·Transfusion·Helen E CampbellUNKNOWN TOPPS Study Investigators

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