Melissa M Cushing1, Monica B Pagano2, Jessica Jacobson3, Joseph Schwartz4, Brenda J Grossman5, Steven Kleinman6, Mi Ah Han7, Claudia S Cohn8. 1. Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, New York. 2. Department of Laboratory Medicine, University of Washington Medical Center, Seattle, Washington. 3. Department of Pathology, NYU Langone Health, New York, New York. 4. Department of Pathology & Cell Biology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York. 5. Department of Pathology & Immunology, Washington University School of Medicine in St. Louis, St. Louis, Missouri. 6. Department of Pathology & Laboratory Medicine, The University of British Columbia, Vancouver, British Columbia. 7. Department of Preventive Medicine, College of Medicine Chosun University, Gwangju, Republic of Korea. 8. Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota.
Abstract
BACKGROUND: A small body of literature assessing the efficacy and safety of pathogen reduced (PR) plasma has been published. STUDY DESIGN AND METHODS: An AABB committee systematically reviewed the literature and graded the clinical trial evidence with the assistance of a GRADE expert. RESULTS: Most studies identified were low quality and had a small sample size; in addition, efficacy and safety were monitored in many different ways making it difficult to quantify therapeutic benefit and risk. The data analyzed in this systematic review showed that pathogen inactivation did not adversely affect the efficacy of S/D or amotosalen plasma transfusions in any patient population studied. In addition, there were no significant safety issues for these patient populations, other than the specific contraindications noted in their respective package inserts. CONCLUSION: Larger, well-designed trials are needed to further evaluate the efficacy and safety of all of the PR plasma products.
BACKGROUND: A small body of literature assessing the efficacy and safety of pathogen reduced (PR) plasma has been published. STUDY DESIGN AND METHODS: An AABB committee systematically reviewed the literature and graded the clinical trial evidence with the assistance of a GRADE expert. RESULTS: Most studies identified were low quality and had a small sample size; in addition, efficacy and safety were monitored in many different ways making it difficult to quantify therapeutic benefit and risk. The data analyzed in this systematic review showed that pathogen inactivation did not adversely affect the efficacy of S/D or amotosalen plasma transfusions in any patient population studied. In addition, there were no significant safety issues for these patient populations, other than the specific contraindications noted in their respective package inserts. CONCLUSION: Larger, well-designed trials are needed to further evaluate the efficacy and safety of all of the PR plasma products.