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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
Background:
Microplasmin, a truncated form of plasmin, degrades fibrin and reacts with the circulating inhibitor alpha(2)-antiplasmin. We investigated the safety and efficacy of intra-catheter microplasmin bolus administration for the restoration of catheter function in long-term venous access catheter thrombosis.
Methods:
This open-label, ascending-dose, pilot study enrolled 31 subjects. Two doses of microplasmin were evaluated, (5 mg and 8 mg) administered via a 2 ml intra-catheter bolus injection in 10 and 21 patients respectively. Catheter function was evaluated 30 min after the first bolus administration. In case of incomplete catheter function restoration, a second bolus was administered with reassessment of catheter function 30 min thereafter.
Results:
After the first bolus, complete restoration of catheter withdrawal function was observed in 5 out of 10 (50%) and 14 of out 21 (66%) subjects treated with 5 mg and 8 mg respectively and in 8 out of 10 (80%) and 18 out of 21 (86%) subjects after a second administration of microplasmin. No bleeding complications nor other adverse events were related to microplasmin.
Conclusions:
In this pilot trial, microplasmin restored catheter function in a safe and effective way.
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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