Predictors of bleeding complications during catHeter-dirEcted thrombolysis for peripheral arterial occlusions (POCHET)

• Published in: PloS one Vol. 19; no. 5; p. e0302830
• Main Authors: Mol, Barend M, Verwer, Maarten C, Fijnheer, Rob, Florie, Jasper, Groot, Oscar A, Hietbrink, Falco, Nijkeuter, Mathilde, Vonken, Evert-Jan P A, van Weel, Vincent, de Kleijn, Dominique P V, de Borst, Gert J
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 09.05.2024; Public Library of Science (PLoS)
• Subjects: Aged; Analysis; Arterial Occlusive Diseases - blood; Arterial Occlusive Diseases - drug therapy; Biobanks; Biology and Life Sciences; Biomarkers; Biomarkers - blood; Bleeding; Blood; Care and treatment; Catheterization; Catheters; Committees; Complications and side effects; Computer and Information Sciences; Development and progression; Engineering and Technology; Ethylenediaminetetraacetic acid; Female; Fibrin; Fibrinogen; Fibrinogen - analysis; Fibrinogen - metabolism; Hemorrhage; Hemorrhage - etiology; Humans; Informed consent; Ischemia; Male; Medical instruments; Medical research; Medicine and Health Sciences; Medicine, Experimental; Middle Aged; Patients; Peripheral Arterial Disease - blood; Peripheral Arterial Disease - drug therapy; Peripheral vascular diseases; Plasma; Plasmin; Prospective Studies; Risk factors; Sample size; Study Protocol; Surgery; Thrombolysis; Thrombolytic Therapy - adverse effects; Thrombolytic Therapy - methods; Netherlands
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0302830

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. 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. 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.