The transfusion-associated dyspnea prospective observation and laboratory assessment study: a protocol for investigating and disambiguating cardiopulmonary and high-grade febrile transfusion reactions in adults

M. McVey, S. Saeed, R. Siddiqui, C. Armali, Amie T Kron, D. Branch, D. Brinc, Liying Zhang, N. Shehata, K. Pavenski, Akash Gupta, Yulia Lin, L. Lieberman, J. Pendergrast, J. Callum, C. Cserti-Gazdewich
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Abstract

Background: Cardiorespiratory transfusion reactions drive most transfusion-related morbidity and mortality. Transfusion-associated circulatory overload and transfusion-related acute lung injury have established causes, important impacts, mitigation options, and revised definitions, while non-conforming CRTRs fall into a category known as transfusion-associated dyspnea. Though procedures to investigate high-risk febrile transfusion reactions are typically rooted in detecting incompatibility or bacterial contamination, a common standard for examining CRTRs is lacking. CRTRs are further challenged by charting limitations, confounding (or enhanced susceptibility) by comorbidities, and/or overlapping insults. Deeper profiling of CRTRs could improve categorizations, reveal best-value diagnostics, and decipher the nature of (and/or minimize) reactions coded as TAD. Methods: The primary objective of this multi-center study is to reduce uncertainty in final conclusions drawn on CRTRs (cases), defined by dyspnea with objective disturbances and/or significant hemodynamic insults, with/without fever (±F). HRFTRs (controls) represent higher-grade F (T≥39°C or chills/rigors or lower-grade F (≥38°C by +Δ1°C) with non-respiratory effects). Patients (goal: 200) consent to additional sampling (≤24h post-TR) to identify contributing factors in case/control presentations, and in diagnostic groups (TRALI, TACO±F, TAD). Mechanistic axes of interest are cardiorenal, hemolytic, leukoagglutinating, biolipid, vasoactive, and inflammatory. Secondary goals include elucidation of real-life “insult-multiplicity” in CRTRs, tests of greatest yield, and distinguishing features in TRALI/TACO/TAD. Conclusions: A deep systematic CRTR probe may not only reduce diagnostic uncertainty but frame biomarker performance and pathologic signatures in definition-specific CRTRs. The re-classifiability or biology of TAD may be better understood. High-quality, mechanistic, true-to-quantity hemovigilance better exposes burdens and management options. Trial Registration: The trial is registered with ClinicalTrials.gov. with registry number NCT04267029.
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输血相关呼吸困难的前瞻性观察和实验室评估研究:调查和消除成人心肺和高热输血反应的方案
背景:心肺输血反应驱动大多数输血相关的发病率和死亡率。输血相关的循环负荷和输血相关的急性肺损伤有明确的原因、重要影响、缓解方案和修订的定义,而不符合标准的crtr属于输血相关呼吸困难的一类。尽管调查高风险热性输血反应的程序通常植根于检测不相容性或细菌污染,但缺乏检查crtr的通用标准。crtr进一步受到图表限制、合并症混淆(或易感性增强)和/或重叠损伤的挑战。对crtr进行更深入的分析可以改进分类,揭示最有价值的诊断,并破译编码为TAD的反应的性质(和/或最小化)。方法:这项多中心研究的主要目的是减少crtr(病例)最终结论的不确定性,crtr(病例)的定义是呼吸困难伴有客观障碍和/或明显的血流动力学损伤,伴有/不伴有发热(±F)。hrftr(对照组)代表较高级别的F (T≥39°C或寒冷/严酷)或较低级别的F(≥38°C +Δ1°C),无呼吸作用。患者(目标:200名)同意进行额外抽样(tr后≤24小时),以确定病例/对照组和诊断组(TRALI, TACO±F, TAD)的影响因素。感兴趣的机制轴是心肾、溶血、白细胞凝集、生物脂、血管活性和炎症。次要目标包括阐明crtr中现实生活中的“侮辱-多重性”,测试最大产量,以及TRALI/TACO/TAD的区别特征。结论:深入系统的CRTR探针不仅可以减少诊断的不确定性,还可以在定义特异性CRTR中构建生物标志物性能和病理特征。TAD的可再分类性或生物学特性可能会得到更好的理解。高质量、机械化、真实量的血液警戒能更好地暴露负担和管理选择。试验注册:该试验已在ClinicalTrials.gov注册。注册号NCT04267029。
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