A pilot trial of microplasmin in patients with long-term venous access catheter thrombosis

Peter Verhamme1, Martine Jerome, Godelieve Goossens

  • 1Department of Vascular Medicine and Haemostasis, University Hospitals Leuven, Catholic University Leuven, Herestraat 49, 3000, Leuven, Belgium. Peter.Verhamme@uz.kuleuven.be

Abstract

Insights

Intra-catheter microplasmin effectively restored function in thrombosed long-term venous access catheters. This safe and effective treatment showed promising results in a pilot study for catheter patency.

Area of Science:

  • Biochemistry
  • Vascular Biology
  • Medical Devices

Background:

  • Microplasmin, a derivative of plasmin, degrades fibrin and interacts with alpha(2)-antiplasmin.
  • Long-term venous access catheters are prone to thrombosis, impairing their function.
  • Restoring catheter function is crucial for patient care and treatment efficacy.

Purpose of the Study:

  • To evaluate the safety and efficacy of intra-catheter microplasmin bolus administration.
  • To assess microplasmin's ability to restore function in thrombosed venous access catheters.
  • To determine optimal dosing for microplasmin in this application.

Main Methods:

  • An open-label, ascending-dose pilot study involving 31 subjects.
  • Two microplasmin doses (5 mg and 8 mg) were administered as intra-catheter boluses.
  • Catheter function was assessed 30 minutes after initial and subsequent administrations.

Main Results:

  • Complete restoration of catheter withdrawal function was achieved in 50% (5 mg) and 66% (8 mg) after the first bolus.
  • Function restoration increased to 80% (5 mg) and 86% (8 mg) after a second microplasmin administration.
  • No bleeding complications or adverse events were associated with microplasmin treatment.

Conclusions:

  • Microplasmin administration safely and effectively restored function in thrombosed venous access catheters.
  • The study supports microplasmin as a viable option for managing catheter-related thrombosis.
  • Further research may confirm these findings in larger patient cohorts.

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