The clinical efficacy of 4℃ stored platelet: a randomized controlled feasibility trial conducted in surgical patients with related bleeding

Abstract

Background Platelets play an important role in acute bleeding.Whether 4℃cold stored platelets (CSPs) can be an effective substitute for platelets at room temperature (RTPs) is rarely reported, we carried out the clinical application observation trial of CSPs in China for the first time. Method A prospective, double-blind, randomized clinical trial was conducted on surgical patients with related bleedingto assess the hemostatic potential of CSPs compared with RTPs. The primary outcomes measured were drainage volume, platelet counts, and Thrombelastography-maximum amplitude. Secondary outcomes included hospital stays, length of stay in the intensive care unit, medical expenses. Results A total of 62 patients were completed the final clinical observation. There were 31 cases ineach of the CSPs group and RTPs group. With in 1–12 hours, 13–24 hours, 25–48 hours, and 49–72 hours after platelet transfusion, drainage volume: 8.5ml/h vs 20.83ml/h ,0.52ml/h vs 5.0ml/h, 3.5ml/h vs 5.0ml/h, 0.63ml/h vs 4.1ml/h. platelet counts:58×109/L vs 79×109/L, 54×109/Lvs77×109/L,63×109/L vs 75×109/L, 66×109/Lvs79×109/L. TEG-MA: 50.1mm vs 52.0mm ,50.1mm vs 54.8mm, 53.0mm vs 56.6, 56.0mm vs 53.2mm.There was no overall difference between the two groups by Generalized estimation equation at different times (Pdrainage=0.933,PPLT counts=0.473,PTEG−MA=0.246). The secondary outcomes (hospital stay, ICU stay time, medical cost, discharge outcome) were no difference between the CSPs group and RTPs group (P > 0.05). There were no significant differences in adverse platelet transfusion events between the groups (P > 0.05). Conclusion CSPs and RTP have equivalent efficacy and safety in the treatment of surgery-related bleeding. This trial provides reliable evidence to support the clinical application of CSPs. Trial registration Chinese Clinical Trial Registry: ChiCTR2000036353;Principal investigator's name: Jiangcun Yang. Date of registration: 22/08/2020.