Effect of In Vivo Administration of Fibrinogen Concentrate Versus Cryoprecipitate on Ex Vivo Clot Degradation in Neonates Undergoing Cardiac Surgery.

IF 4.6 2区 医学 Q1 ANESTHESIOLOGY Anesthesia and analgesia Pub Date : 2024-08-08 DOI:10.1213/ANE.0000000000007123
Laura A Downey, Nina Moiseiwitsch, Kimberly Nellenbach, Yijin Xiang, Ashley C Brown, Nina A Guzzetta
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Abstract

Background: Neonates undergoing cardiac surgery require fibrinogen replacement to restore hemostasis after cardiopulmonary bypass (CPB). Cryoprecipitate is often the first-line treatment, but recent studies demonstrate that fibrinogen concentrate (RiaSTAP; CSL Behring) may be acceptable in this population. This investigator-initiated, randomized trial compares cryoprecipitate to fibrinogen concentrate in neonates undergoing cardiac surgery (ClinicalTrials.gov NCT03932240). The primary end point was the percent change in ex vivo clot degradation from baseline at 24 hours after surgery between groups. Secondary outcomes included intraoperative blood transfusions, coagulation factor levels, and adverse events.

Methods: Neonates were randomized to receive cryoprecipitate (control group) or fibrinogen concentrate (study group) as part of a post-CPB transfusion algorithm. Blood samples were drawn at 4 time points: presurgery (T1), after treatment (T2), arrival to the intensive care unit (ICU) (T3), and 24 hours postsurgery (T4). Using the mixed-effect models, we analyzed the percent change in ex vivo clot degradation from a patient's presurgery baseline at each time point. Intraoperative blood product transfusions, coagulation factor levels, perioperative laboratory values, and adverse events were collected.

Results: Thirty-six neonates were enrolled (intent to treat [ITT]). Thirteen patients in the control group and seventeen patients in the study group completed the study per protocol (PP). After normalizing to the patient's own baseline (T1), no significant differences were observed in clot degradation at T2 or T3. At T4, patients in the study group had greater degradation when compared to those in the control group (826.5%, 95% confidence interval [CI], 291.1-1361.9 vs -545.9%, 95% CI, -1081.3 to -10.4; P < .001). Study group patients received significantly less median post-CPB transfusions than control group patients (ITT, 27.2 mL/kg [19.0-36.9] vs 41.6 [29.2-52.4]; P = .043; PP 26.7 mL/kg [18.8-32.2] vs 41.2 mL/kg [29.0-51.4]; P < .001). No differences were observed in bleeding or thrombotic events.

Conclusions: Neonates who received fibrinogen concentrate, as compared to cryoprecipitate, have similar perioperative ex vivo clot degradation with faster degradation at 24 hours postsurgery, less post-CPB blood transfusions, and no increased bleeding or thrombotic complications. Our findings suggest that fibrinogen concentrate adequately restores hemostasis and reduces transfusions in neonates after CPB without increased bleeding or thrombosis risk.

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体内注射浓缩纤维蛋白原和冷冻沉淀物对接受心脏手术的新生儿体内血栓降解的影响
背景:接受心脏手术的新生儿在心肺旁路术(CPB)后需要补充纤维蛋白原以恢复止血。低温沉淀通常是一线治疗方法,但最近的研究表明,浓缩纤维蛋白原(RiaSTAP;CSL Behring)在这类人群中也是可以接受的。这项由研究者发起的随机试验对接受心脏手术的新生儿使用低温沉淀和浓缩纤维蛋白原进行了比较(ClinicalTrials.gov NCT03932240)。主要终点是各组间手术后 24 小时体内外血块降解率与基线相比的百分比变化。次要结果包括术中输血、凝血因子水平和不良事件:新生儿随机接受低温沉淀(对照组)或浓缩纤维蛋白原(研究组),作为 CPB 术后输血算法的一部分。在 4 个时间点抽取血样:手术前(T1)、治疗后(T2)、到达重症监护室(ICU)(T3)和手术后 24 小时(T4)。利用混合效应模型,我们分析了每个时间点患者体内外血块降解率与手术前基线相比的变化百分比。我们还收集了术中血制品输注、凝血因子水平、围手术期实验室值和不良事件:36名新生儿入选(意向治疗[ITT])。对照组和研究组分别有 13 名和 17 名患者按方案(PP)完成了研究。根据患者自身的基线(T1)进行归一化处理后,在 T2 或 T3 阶段未观察到血凝块降解的显著差异。在 T4 阶段,研究组患者的血块降解程度高于对照组(826.5%,95% 置信区间 [CI],291.1-1361.9 vs -545.9%,95% CI,-1081.3 to -10.4;P < .001)。研究组患者 CPB 后输血中位数明显少于对照组患者(ITT,27.2 mL/kg [19.0-36.9] vs 41.6 [29.2-52.4];P = .043;PP 26.7 mL/kg [18.8-32.2] vs 41.2 mL/kg [29.0-51.4];P < .001)。在出血或血栓事件方面未观察到差异:结论:与低温沉淀相比,接受浓缩纤维蛋白原的新生儿围手术期体内外血块降解相似,术后24小时降解更快,CPB术后输血更少,出血或血栓并发症没有增加。我们的研究结果表明,浓缩纤维蛋白原可充分恢复止血功能并减少 CPB 后新生儿的输血量,同时不会增加出血或血栓风险。
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来源期刊
Anesthesia and analgesia
Anesthesia and analgesia 医学-麻醉学
CiteScore
9.90
自引率
7.00%
发文量
817
审稿时长
2 months
期刊介绍: Anesthesia & Analgesia exists for the benefit of patients under the care of health care professionals engaged in the disciplines broadly related to anesthesiology, perioperative medicine, critical care medicine, and pain medicine. The Journal furthers the care of these patients by reporting the fundamental advances in the science of these clinical disciplines and by documenting the clinical, laboratory, and administrative advances that guide therapy. Anesthesia & Analgesia seeks a balance between definitive clinical and management investigations and outstanding basic scientific reports. The Journal welcomes original manuscripts containing rigorous design and analysis, even if unusual in their approach.
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