drugset / Trial / NCT04083807

Efficacy and Safety of TISSEEL Lyo Compared to Manual Compression as an Adjunct to Haemostasis

NCT04083807 ↗

Phase 3 Completed 104 enrolled Baxter Healthcare Corporation
RandomizedParallel-groupSingle-blindTreatment

Summary

The primary objective of the study is to evaluate the efficacy of TISSEEL Lyo for haemostasis in patients receiving peripheral vascular prosthetic expanded polytetrafluoroethylene (ePTFE) conduits, as compared to a control arm treated with manual compression with surgical gauze pads.

Timeline

Start
2019-07-10
Primary completion
2019-10-22
Completion
2019-10-22

Drugs

EvaluationDrugModalityDoseRoute
Subject TISSEEL Lyo Protein / enzyme biologic 2 ml —

Indications

No indication recorded.