Editorial assistance in the form of drafting technical portions of the Methods and Results sections, redrawing figures and formatting was provided by Carolyn Bowler, PhD, CMPP, of Apollo, OPEN Health Communications, funded by Novo Nordisk A/S, in accordance with Good Publication Practice (GPP) guidelines (www.ismpp.org/gpp-2022)
Our team generally advises against pre-loading syringes for long-term storage
I get a lot of pushback on that from physicians saying, Why would you want to burden a patient with that knowledge? I welcome that debate because it opens a discussion: Do you or do you not believe that this a deterministic gene
Have you ever worried about the possible side effects, like: nausea injection site reactions mild fatigue
Researchers who try to accelerate this schedule almost always regret it
Abbreviations AE: Adverse event AKI: Acute kidney injury BARDA: Biological Advanced Research and Development Authority CDC : Centers for Disease Control and Prevention CPB: Cardiopulmonary bypass CRO : Clinical research organization CVS: Cardiovascular surgery DAT: Direct antiglobulin test DSMB: Data and Safety Monitoring Board EDC : Electronic data capture eCRF: Electronic case report forms EDQM : European Directorate for the Quality of Medicines & Healthcare FDA: Food and Drug Administration GCP: Good Clinical Practice GSH: Glutathione HLA: Human leukocyte antigen IAT: Indirect antiglobulin test IRB: Institutional review board IWRS : Interactive Web Response System mITT: Modified intention-to-treat NHSN: National Healthcare Safety Network PPS: Per-protocol set PRT: Pathogen reduction technology RBC: Red blood cell S-303: Amustaline SAE: Serious adverse event SCD : Sickle cell disease sCr: Serum creatinine SROS: Study red blood cells only set RRT : Renal replacement therapy TTI: Transfusion-transmitted infection TA-GVHD: Transfusion-associated graft-versus-host disease TEAE: Transfusion emergent adverse event TR: Transfusion reaction TRALI: Transfusion-related acute lung injury References Godbey EA, Thibodeaux SR
