In vitro protamine addition for coagulation assessment using TEG 6s system during cardiopulmonary bypass: a pilot study.

IF 1.1 4区 医学 Q4 CARDIAC & CARDIOVASCULAR SYSTEMS General Thoracic and Cardiovascular Surgery Pub Date : 2025-03-01 Epub Date: 2024-07-17 DOI:10.1007/s11748-024-02061-7
Koichi Yoshinaga, Yusuke Iizuka, Yoshihiko Chiba, Yusuke Sasabuchi, Masamitsu Sanui
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Abstract

Objective: Systemic heparinization during cardiopulmonary bypass (CPB) can significantly affect thromboelastography (TEG). This study investigated the feasibility of adding protamine in vitro to allow assessment of coagulation status using the TEG 6s system during CPB.

Methods: In this prospective observational study, 21 patients undergoing elective cardiac valve surgery were evaluated. During CPB, protamine was added in vitro to the heparinized blood of these patients at a concentration of 0.05 mg/mL and analyzed with the TEG 6s (Pre). The TEG parameters were compared to those analyzed after CPB withdrawal and systemic protamine administration (Post).

Results: The citrated kaolin maximal amplitude (CK-MA) and the citrated functional fibrinogen maximal amplitude (CFF-MA) exhibited strong correlations between Pre and Post measurements (r = 0.790 and 0.974, respectively, P < 0.001 for both), despite significant mean differences (-2.23 mm for CK-MA and -0.68 mm for CFF-MA). Bland-Altman analysis showed a clinically acceptable agreement between Pre and Post measurement of CK-MA and CFF-MA (the percentage error was 10.6% and 12.2%, respectively). In contrast, the citrated kaolin reaction time (CK-R) showed no significant correlation between Pre and Post measurements (r = 0.328, P = 0.146), with a mean difference of 1.42 min (95% CI: -0.45 to 3.29).

Conclusions: In vitro protamine addition allows assessment of coagulation status during CPB using the TEG 6s system. CK-MA and CFF-MA measured during CPB using this method revealed a strong correlation and agreement with post-CPB measurements, suggesting that our method potentially facilitates early prediction of post-CPB coagulation status and decision-making on transfusion strategies.

Clinical trial registration: The study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR, registration number: UMIN000041097, date of registration: July 13, 2020, https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046925 ) before the recruitment of participants.

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在心肺旁路过程中使用 TEG 6s 系统在体外添加原胺进行凝血评估:一项试验研究。
目的:心肺旁路术(CPB)期间全身肝素化会严重影响血栓弹性成像(TEG)。本研究探讨了在体外添加原胺的可行性,以便在 CPB 期间使用 TEG 6s 系统评估凝血状态:在这项前瞻性观察研究中,对 21 名接受择期心脏瓣膜手术的患者进行了评估。在 CPB 期间,体外向这些患者的肝素化血液中加入浓度为 0.05 毫克/毫升的质胺,并用 TEG 6s 系统(Pre)进行分析。将 TEG 参数与撤除 CPB 和全身使用质胺(后)后分析的参数进行比较:结果:枸橼酸化高岭土最大振幅(CK-MA)和枸橼酸化功能性纤维蛋白原最大振幅(CFF-MA)在前和后的测量值之间表现出很强的相关性(r = 0.790 和 0.974,P 结论:体外添加原胺可评估枸橼酸化高岭土和枸橼酸化功能性纤维蛋白原的最大振幅:体外添加原胺可利用 TEG 6s 系统评估 CPB 期间的凝血状态。使用该方法在 CPB 期间测量的 CK-MA 和 CFF-MA 与 CPB 后的测量结果具有很强的相关性和一致性,这表明我们的方法可能有助于早期预测 CPB 后的凝血状态和输血策略的决策:本研究已在美国大学医院医学信息网临床试验注册中心(UMIN-CTR,注册号:UMIN000041097,日期:2012-01-01)注册:UMIN000041097,注册日期:2020年7月13日:注册日期:2020 年 7 月 13 日,https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046925 ) 后方可招募参与者。
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来源期刊
General Thoracic and Cardiovascular Surgery
General Thoracic and Cardiovascular Surgery Medicine-Pulmonary and Respiratory Medicine
CiteScore
2.70
自引率
8.30%
发文量
142
期刊介绍: The General Thoracic and Cardiovascular Surgery is the official publication of The Japanese Association for Thoracic Surgery and The Japanese Association for Chest Surgery, the affiliated journal of The Japanese Society for Cardiovascular Surgery, that publishes clinical and experimental studies in fields related to thoracic and cardiovascular surgery.
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