The Clinical Efficacy of 4 ℃ Stored Platelet: a Randomized Controlled Feasibility Trial Conducted in Surgical Patients with Hemorrhage

doi:10.3969/j.issn.1671-2587.2025.02.001

JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE ›› 2025, Vol. 27 ›› Issue (2): 145-155.DOI: 10.3969/j.issn.1671-2587.2025.02.001

The Clinical Efficacy of 4 ℃ Stored Platelet: a Randomized Controlled Feasibility Trial Conducted in Surgical Patients with Hemorrhage

SUN Yang¹, NIU Jiameng¹, XING Lili¹, MA Ting¹, DU Gongliang², LI Xuewen³, WANG Yaqin⁴, WANG Liqin¹, CHEN Ping¹, WANG Wenhua¹, YANG Yingqun¹, SONG Aowei¹, XIE Xinxin¹, SONG Yaojun¹, WANG Miaoni¹, CHANG Jingyan¹, TIAN Fenfang¹, YANG Jiangcun¹

¹Department of Transfusion Medicine;
²Department of Emergency Surgery;
³Department of Cardiac Surgery;
⁴Department of Obstetrics, Shaanxi People's Hospital, Xi'an, 710068

Received:2024-12-07 Online:2025-04-20 Published:2025-04-17

Abstract

Abstract: Objective To observe the clinical efficacy and adverse reactions of CSP in patients with surgical hemorrhage. Methods A prospective, double-blind, randomized clinical trial was conducted on surgical patients with related bleeding to assess the hemostatic function of CSP compared with RTP. The primary outcomes measured were drainage volume, platelet counts, and Thrombelastography-maximum amplitude. Secondary outcomes included hospital stays, the intensive care unit stays and medical cost. Results A total of 62 patients were completed the final clinical observation. There were 31 cases in each of the CSP group and RTP group. Within 1~12 hours, 13~24 hours, 25~48 hours, and 49~72 hours after platelet transfusion, drainage volume: 8.5 mL/h vs 20.83 mL/h, 0.52 mL/h vs 5.0 mL/h, 3.5 mL/h vs 5.0 mL/h, 0.63 mL/h vs 4.1 mL/h. platelet counts: 58×10⁹/L vs 79×10⁹/L, 54×10⁹/L vs 77×10⁹/L, 63×10⁹/L vs 75×10⁹/L, 66×10⁹/L vs 79×10⁹/L. TEG-MA: 50.1 mm vs 52.0 mm, 50.1 mm vs 54.8 mm, 53.0 mm vs 56.6, 56.0 mm vs 53.2 mm. There were no overall differences between the two groups by Generalized Estimating Equations at different times (P_Drainage=0.933, P_PLTcounts=0.473, P_TEG-MA=0.246). The secondary outcomes (hospital stays, ICU stays, medical cost, discharge outcome) were no differences between the CSP group and RTP group (P>0.05). There were no significant differences in adverse platelet transfusion events between the groups (P>0.05). Conclusion CSP and RTP have equivalent efficacy and safety in the treatment of surgical hemorrhage. This trial provides reliable evidence to support the clinical application of CSP.

Key words: Platelet, Platelet storage, Cold-stored platelets, Room temperature platelets, Hemorrhage

CLC Number:

R331.1⁺43R457.1

SUN Yang, NIU Jiameng, XING Lili, MA Ting, DU Gongliang, LI Xuewen, WANG Yaqin, WANG Liqin, CHEN Ping, WANG Wenhua, YANG Yingqun, SONG Aowei, XIE Xinxin, SONG Yaojun, WANG Miaoni, CHANG Jingyan, TIAN Fenfang, YANG Jiangcun. The Clinical Efficacy of 4 ℃ Stored Platelet: a Randomized Controlled Feasibility Trial Conducted in Surgical Patients with Hemorrhage[J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2025, 27(2): 145-155.

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The Clinical Efficacy of 4 ℃ Stored Platelet: a Randomized Controlled Feasibility Trial Conducted in Surgical Patients with Hemorrhage

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