Practical Anemia Bundle for Sustained Blood Recovery (PABST-BR) in critical illness: a protocol for a randomised controlled trial.
Practical Anemia Bundle for Sustained Blood Recovery (PABST-BR) in critical illness: a protocol for a randomised controlled trial.
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DOI：
10.1136/bmjopen-2022-064017
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发表时间：
2022-12-02
期刊：
影响因子：
2.9
通讯作者：
中科院分区：
文献类型：
--
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贫血在危重疾病中非常普遍，并与住院期间和住院后的预后受损有关。然而，旨在减轻或治疗危重疾病期间贫血的干预措施对住院后血红蛋白恢复和功能结果的影响尚不清楚。用于持续血液恢复的实用贫血束(Pabst-BR)临床试验是一项务实、开放标签、平行分组、单中心、随机的临床试验，评估多方面贫血预防和治疗策略与改善危重疾病后血红蛋白浓度和功能结果的标准护理的影响。这项干预措施将在中到重度贫血症(即血红蛋白100 g/L)患者的危重病情早期实施，包括三个部分：(1)优化的静脉切开术，(2)临床决策支持和(3)针对贫血症根本病因的药理贫血症治疗。面对面的评估将在入院后1个月和3个 月进行，以进行实验室评估和多维功能结果评估。主要结果是不同组之间的血红蛋白浓度差异，次要终点是与贫血相关的疲劳、身体功能、认知、精神健康、生活质量、静脉切除量和频率、输血、再入院和住院后一年的死亡率。这项研究已经得到了美国明尼苏达州梅奥诊所机构审查委员会的批准。根据机构审查委员会和研究资助者、国家卫生研究院(NIH)的国家心肺和血液研究所的政策，制定了数据安全监测计划。这项研究将符合美国国立卫生研究院的数据共享和传播政策。结果将在国家和国际会议上公布，并在同行评议的期刊上发表。设计和测试策略以优化血红蛋白恢复和改善危重疾病后的功能结果仍然是重要的研究空白。Pabst-BR试验将推动更大规模的多中心临床试验的发展。NCT05167734。
Anaemia is highly prevalent in critical illness and is associated with impaired outcomes during and after hospitalisation. However, the impact of interventions designed to attenuate or treat anaemia during critical illness on post-hospitalisation haemoglobin recovery and functional outcomes is unclear. The Practical Anemia Bundle for Sustained Blood Recovery (PABST-BR) clinical trial is a pragmatic, open-label, parallel group, single-centre, randomised clinical trial assessing the impact of a multifaceted anaemia prevention and treatment strategy versus standard care for improvement of haemoglobin concentrations and functional outcomes after critical illness. The intervention, which will be delivered early in critical illness for those with moderate-to-severe anaemia (ie, haemoglobin <100 g/L), includes three components: (1) optimised phlebotomy, (2) clinical decision support and (3) pharmacological anaemia treatment directed at the underlying aetiology of anaemia. In-person assessments will occur at 1 and 3 months post-hospitalisation for laboratory evaluations and multidimensional functional outcome assessments. The primary outcome is differences in haemoglobin concentrations between groups, with secondary endpoints of anaemia-related fatigue, physical function, cognition, mental health, quality of life, phlebotomy volumes and frequency, transfusions, readmissions and mortality through 1-year post-hospitalisation. The study has been approved by the Institutional Review Board of the Mayo Clinic in Minnesota, USA. A Data Safety Monitoring Plan has been created in accordance with the policies of the Institutional Review Board and the study funder, the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH). The study will comply with NIH data sharing and dissemination policies. Results will be presented at national and international meetings and published in peer-reviewed journals. Designing and testing strategies to optimise haemoglobin recovery and improve functional outcomes after critical illness remain important research gaps. The PABST-BR trial will inform the development of a larger multicentre clinical trial. NCT05167734.
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DOI：
10.1016/j.mayocpiqo.2020.08.007
发表时间：
2021-03
期刊：
Mayo Clinic proceedings. Innovations, quality & outcomes
影响因子：
--
作者：
Wu Y;Spaulding AC;Borkar S;Shoaei MM;Mendoza M;Grant RL;Barber BW;Johns GS;Franco PM
通讯作者：
Franco PM
影响因子：
45.3
作者：
Leyland-Jones, B;Semiglazov, V;Vercammen, E
通讯作者：
Vercammen, E
影响因子：
168.9
作者：
Henke, M;Laszig, R;Frommhold, H
通讯作者：
Frommhold, H
影响因子：
3.1
作者：
通讯作者：
--
影响因子：
10.7
作者：
van der Laan, S.;Billah, T.;Litton, E.
通讯作者：
Litton, E.