Hemoperfusion with HA380 in acute type A aortic dissection patients undergoing aortic arch operation (HPAO): a randomized, controlled, double-blind clinical trial.
Hemoperfusion with HA380 in acute type A aortic dissection patients undergoing aortic arch operation (HPAO): a randomized, controlled, double-blind clinical trial.
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HA380血液灌流治疗急性A型主动脉夹层患者行主动脉弓手术（HPAO）：一项随机、对照、双盲临床试验
DOI：
10.1186/s13063-020-04858-2
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发表时间：
2020-11-23
期刊：
影响因子：
2.5
通讯作者：
Yao H
中科院分区：
文献类型：
--
作者：
Yang J;Ji D;Zhu YQ;Ren Y;Zhang X;Dai HY;Sun X;Zhou Y;Chen ZY;Li QG;Yao H
在急性A型主动脉夹层(ATAAD)的外科治疗中，体外循环(CPB)是导致严重全身炎症反应综合征(SIRS)的重要原因。在有弓血管受累的患者中，广泛的外科修复通常需要长时间使用CPB，并导致广泛的炎症反应。体外循环期间释放的细胞因子和趋化因子有助于SIRS的进展，增加围手术期并发症，并对手术结果产生负面影响。细胞因子吸附剂(HA380)有望在体外循环期间降低细胞因子水平，从而可能减少术中和术后的炎症反应。本研究的目的是探讨HA380能否降低体外循环和深低温停循环(深低温停循环)下ATAAD患者的炎性细胞因子水平，减少围手术期并发症。本研究旨在招募88例ATAAD合并主动脉弓受累的患者，他们将接受体外循环和深低温心脏停搏，以修复夹层的主动脉。患者将被随机分为两组：单纯体外循环/深低温停循环组(对照组)和体外循环/深低温停循环+HA380血液灌流组(干预组)，每组44例。对照组仅行体外循环和深低温体外循环，干预组在体外循环和深低温体外循环的基础上，应用HA380持续血液灌流。主要结果是主要围手术期并发症的综合结果。次要结果包括相关的炎症标志物、凝血参数和较小的围手术期并发症。为了综合评价血液灌流对围术期预后的影响，我们还将确定围手术期全因死亡率、ICU住院时间和总住院费用是否存在差异。讨论在本次试验中，血液灌流将应用于CPB和DHCA手术的患者，以修复累及主动脉弓的主动脉。这项试验旨在测试我们的血液灌流设备(HA380)在这种环境下的安全性和有效性。试验完成后，我们将确定HA380在降低围手术期促炎细胞因子水平方面是否有效。此外，我们还将验证促炎症细胞因子水平的降低(如果存在)是否转化为患者结果的改善。试验登记临床试验.gov NCT04007484。注册日期为2019年7月1日(追溯注册)。
BackgroundCardiopulmonary bypass (CPB) is an important cause of significant systemic inflammatory response syndrome (SIRS) in the surgical treatment of acute type A aortic dissection (ATAAD). In patients with arch vessel involvement, extensive surgical repairs often necessitate prolonged use of CPB and results in extensive inflammatory responses. Cytokines and chemokines released during CPB contribute to the progression of SIRS, increase perioperative complications, and negatively impact surgical outcomes. A cytokine adsorber (HA380) is expected to reduce the level of cytokines during CPB, which may decrease both intraoperative and postoperative inflammation. The purpose of this study is to investigate if HA380 is able to reduce the levels of inflammatory cytokines and decrease perioperative complications in ATAAD patients undergoing CPB and deep hypothermic circulatory arrest (DHCA).MethodsThis study is a single-center, randomized, controlled, double-blind clinical trial. The study aims to recruit 88 patients with ATAAD and aortic arch involvement who will undergo CPB and DHCA to repair the dissected aorta. Patients will be randomized equally into the CPB/DHCA only group (control group) and the CPB/DHCA + HA380 hemoperfusion group (intervention group), with 44 patients each. Patients in the control group will undergo CPB and DHCA only, while patients in the intervention group will undergo continuous hemoperfusion with HA380, in addition to CPB and DHCA. The primary outcome is a composite of major perioperative complications. The secondary outcomes include related inflammatory markers, coagulation parameters, and minor perioperative complications. To comprehensively evaluate the effect of hemoperfusion on the perioperative outcomes, we will also determine if there are differences in perioperative all-cause mortality, length of ICU stay, and total hospitalization costs.DiscussionIn the current trial, hemoperfusion will be applied in patients undergoing CPB and DHCA for repair of the aorta involving the aortic arch. This trial aims to test the safety and efficacy of our hemoperfusion device (HA380) in such settings. Upon completion of the trial, we will determine if HA380 is effective in reducing perioperative proinflammatory cytokine levels. Further, we will also verify if reduction in the proinflammatory cytokine levels, if present, translates to improvement in patient outcomes.Trial registrationClinicalTrials.gov NCT04007484 . Registered on 1 July 2019 (retrospectively registered).
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影响因子：
37.8
作者：
Go AS;Mozaffarian D;Roger VL;Benjamin EJ;Berry JD;Blaha MJ;Dai S;Ford ES;Fox CS;Franco S;Fullerton HJ;Gillespie C;Hailpern SM;Heit JA;Howard VJ;Huffman MD;Judd SE;Kissela BM;Kittner SJ;Lackland DT;Lichtman JH;Lisabeth LD;Mackey RH;Magid DJ;Marcus GM;Marelli A;Matchar DB;McGuire DK;Mohler ER 3rd;Moy CS;Mussolino ME;Neumar RW;Nichol G;Pandey DK;Paynter NP;Reeves MJ;Sorlie PD;Stein J;Towfighi A;Turan TN;Virani SS;Wong ND;Woo D;Turner MB;American Heart Association Statistics Committee and Stroke Statistics Subcommittee
通讯作者：
American Heart Association Statistics Committee and Stroke Statistics Subcommittee
DOI：
10.1186/cc8166
发表时间：
2009
期刊：
Critical care (London, England)
影响因子：
--
作者：
Delannoy B;Guye ML;Slaiman DH;Lehot JJ;Cannesson M
通讯作者：
Cannesson M
影响因子：
8.8
作者：
Hogue, CW;Sundt, T;Dávila-Román, VG
通讯作者：
Dávila-Román, VG
影响因子：
3
作者：
Montin, Diego Pomare;Ankawi, Ghada;Ronco, Claudio
通讯作者：
Ronco, Claudio
影响因子：
4.6
作者：
Franke, A;Lante, W;Markewitz, A
通讯作者：
Markewitz, A