PDF(Pubmed)
Abstract：
BACKGROUND: The risk of major bleeding complications in catheter directed thrombolysis (CDT) for acute limb ischemia (ALI) remains high, with reported major bleeding complication rates in up to 1 in every 10 treated patients. Fibrinogen was the only predictive marker used for bleeding complications in CDT, despite the lack of high quality evidence to support this. Therefore, recent international guidelines recommend against the use of fibrinogen during CDT. However, no alternative biomarkers exist to effectively predict CDT-related bleeding complications. The aim of the POCHET biobank is to prospectively assess the rate and etiology of bleeding complications during CDT and to provide a biobank of blood samples to investigate potential novel biomarkers to predict bleeding complications during CDT.
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.
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.
摘要：
背景：急性肢体缺血（ALI）的导管直接溶栓（CDT）中大出血并发症的风险仍然很高，据报道，每10例接受治疗的患者中有1例发生严重出血并发症。纤维蛋白原是CDT出血并发症的唯一预测指标，尽管缺乏高质量的证据来支持这一点。因此,最近的国际指南建议在CDT期间不使用纤维蛋白原。然而,没有替代的生物标志物可以有效预测CDT相关出血并发症.POCHET生物样本库的目的是前瞻性评估CDT期间出血并发症的发生率和病因，并提供血液样本的生物样本库，以研究潜在的新型生物标志物来预测CDT期间的出血并发症。
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。
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。
