A study protocol for a randomised controlled trial evaluating clinical effects of platelet transfusion products: the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) trial

BMJ Open
Paula F YpmaPREPAReS Study Group

Abstract

Patients with chemotherapy-induced thrombocytopaenia frequently experience minor and sometimes severe bleeding complications. Unrestrictive availability of safe and effective blood products is presumed by treating physicians as well as patients. Pathogen reduction technology potentially offers the opportunity to enhance safety by reducing bacterial and viral contamination of platelet products along with a potential reduction of alloimmunisation in patients receiving multiple platelet transfusions. To test efficacy, a randomised, single-blinded, multicentre controlled trial was designed to evaluate clinical non-inferiority of pathogen-reduced platelet concentrates treated by the Mirasol system, compared with standard plasma-stored platelet concentrates using the percentage of patients with WHO grade ≥ 2 bleeding complications as the primary endpoint. The upper limit of the 95% CI of the non-inferiority margin was chosen to be a ≤ 12.5% increase in this percentage. Bleeding symptoms are actively monitored on a daily basis. The adjudication of the bleeding grade is performed by 3 adjudicators, blinded to the platelet product randomisation as well as by an automated computer algorithm. Interim analyses evaluating bleeding complicat...Continue Reading

References

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Citations

Mar 30, 2017·Platelets·Abdimajid OsmanPatrick Provost
Aug 2, 2017·The Cochrane Database of Systematic Reviews·Lise J EstcourtMichael F Murphy
Apr 21, 2016·Medical Science Monitor : International Medical Journal of Experimental and Clinical Research·Mustafa KorogluSeyit Ali Kayis

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Methods Mentioned

BETA
whole blood collection
dynamic light scattering

Software Mentioned

PREPAReS
ProMISe
ProMISe ( Manager Internet

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