METHODS: The POCHET biobank is a multicentre prospective biobank. After informed consent, all consecutive patients with lower extremity ALI eligible for CDT are included. All patients are treated according to a predefined standard operating procedure which is aligned in all participating centres. Baseline and follow-up data are collected. Prior to CDT and subsequently every six hours, venous blood samples are obtained and stored in the biobank for future analyses. The primary outcome is the occurrence of non-access related major bleeding complications, which is assessed by an independent adjudication committee. Secondary outcomes are non-major bleeding complications and other CDT related complications. Proposed biomarkers to be investigated include fibrinogen, to end the debate on its usefulness, anti-plasmin and D-Dimer.
CONCLUSIONS: The POCHET biobank provides contemporary data and outcomes of patients during CDT for ALI, coupled with their blood samples taken prior and during CDT. Thereby, the POCHET biobank is a real world monitor on biomarkers during CDT, supporting a broad spectrum of future research for the identification of patients at high risk for bleeding complications during CDT and to identify new biomarkers to enhance safety in CDT treatment.
方法:POCHET生物样本库是一个多中心前瞻性生物样本库。知情同意后,纳入所有符合CDT条件的连续下肢ALI患者.所有患者均根据预定义的标准操作程序进行治疗,该程序在所有参与中心中保持一致。收集基线和随访数据。在CDT之前,随后每六个小时,获得静脉血样本并将其存储在生物库中以备将来分析。主要结果是非通路相关的主要出血并发症的发生。由一个独立的裁决委员会评估。次要结果是非大出血并发症和其他CDT相关并发症。拟研究的生物标志物包括纤维蛋白原,为了结束关于它有用性的辩论,抗纤溶酶和D-二聚体。
结论:POCHET生物样本库提供了ALICDT期间患者的当代数据和结果,再加上他们在CDT之前和期间采集的血液样本。因此,POCHET生物库是CDT期间生物标志物的真实世界监测器,支持广泛的未来研究,以识别CDT期间出血并发症的高风险患者,并确定新的生物标志物,以提高CDT治疗的安全性。