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Predictors of bleeding complications during catHeter-dirEcted thrombolysis for peripheral arterial occlusions
Barend M Mol1, Maarten C Verwer1, Rob Fijnheer2
1Department of Vascular Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Insights
Catheter directed thrombolysis for acute limb ischemia has high bleeding risks. The POCHET biobank collects data and samples to find new biomarkers for predicting bleeding complications during this procedure.
Area of Science:
- Vascular Surgery
- Interventional Radiology
- Biomarker Discovery
Background:
- Catheter directed thrombolysis (CDT) for acute limb ischemia (ALI) carries a significant risk of major bleeding complications, affecting up to 10% of patients.
- Fibrinogen, previously the sole marker for bleeding risk, is no longer recommended due to insufficient evidence, leaving a gap in predictive capabilities.
- Current guidelines recommend against fibrinogen use in CDT, highlighting the urgent need for alternative biomarkers to predict bleeding.
Purpose of the Study:
- To prospectively evaluate the incidence and causes of bleeding complications in patients undergoing CDT for ALI.
- To establish a biobank of blood samples from these patients for investigating novel predictive biomarkers.
- To address the ongoing debate regarding fibrinogen's utility and explore other potential markers like anti-plasmin and D-Dimer.
Main Methods:
- The POCHET biobank is a multicenter, prospective study enrolling consecutive patients with lower extremity ALI undergoing CDT.
- Standardized treatment protocols and data collection are implemented across all participating centers.
- Venous blood samples are collected pre-procedure and every six hours post-procedure for storage and future analysis.
Main Results:
- The primary outcome is the assessment of non-access related major bleeding complications by an independent committee.
- Secondary outcomes include non-major bleeding events and other CDT-related complications.
- The biobank will facilitate the investigation of fibrinogen, anti-plasmin, and D-Dimer as potential biomarkers.
Conclusions:
- The POCHET biobank offers real-world data and biosamples for ongoing research into CDT for ALI.
- It aims to identify patients at high risk for bleeding complications, thereby improving treatment safety.
- This resource supports the discovery of new biomarkers to enhance patient safety during CDT procedures.
Introduction:
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.
Discussion And Conclusion:
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.
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