A randomized controlled clinical trial evaluating the performance and safety of platelets treated with MIRASOL pathogen reduction technology
| Autor: | Paolo Rebulla, L. Bardiaux, Jean-Daniel Tissot, Richard J. Cook, Gines Escolar, T. Kondo, B. Lafeuillade, Jeffrey McCullough, M. Debost, Jean-Yves Cahn, R. Schots, Raymond P. Goodrich, Reza Tabrizi, B. Stouch, Jean-Michel Boiron, Mauricette Michallet, Nancy M. Heddle, C. Le, Bruno Lioure, Daniel R. Ambruso, J‐L. Harousseau, G Folléa, Luc Sensebe, J. Bruhwyler, P. Mintz, J. P. Cazenave |
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| Rok vydání: | 2010 |
| Předmět: |
medicine.medical_specialty
business.industry Immunology food and beverages Pathogen reduction Riboflavin Hematology Confidence interval law.invention Surgery Clinical trial Standard error Randomized controlled trial Blood product law Internal medicine medicine Immunology and Allergy Platelet business |
| Zdroj: | Transfusion. 50:2362-2375 |
| ISSN: | 0041-1132 |
| DOI: | 10.1111/j.1537-2995.2010.02694.x |
| Popis: | BACKGROUND: Pathogen reduction of platelets (PRT-PLTs) using riboflavin and ultraviolet light treatment has undergone Phase 1 and 2 studies examining efficacy and safety. This randomized controlled clinical trial (RCT) assessed the efficacy and safety of PRT-PLTs using the 1-hour corrected count increment (CCI1hour) as the primary outcome. STUDY DESIGN AND METHODS: A noninferiority RCT was performed where patients with chemotherapy-induced thrombocytopenia (six centers) were randomly allocated to receive PRT-PLTs (Mirasol PRT, CaridianBCT Biotechnologies) or reference platelet (PLT) products. The treatment period was 28 days followed by a 28-day follow-up (safety) period. The primary outcome was the CCI1hour determined using up to the first eight on-protocol PLT transfusions given during the treatment period. RESULTS: A total of 118 patients were randomly assigned (60 to PRT-PLTs; 58 to reference). Four patients per group did not require PLT transfusions leaving 110 patients in the analysis (56 PRT-PLTs; 54 reference). A total of 541 on-protocol PLT transfusions were given (303 PRT-PLTs; 238 reference). The least square mean CCI was 11,725 (standard error [SE], 1.140) for PRT-PLTs and 16,939 (SE, 1.149) for the reference group (difference, −5214; 95% confidence interval, −7542 to −2887; p |
| Databáze: | OpenAIRE |
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