drugset / Trial / NCT03613584

Von Willebrand Factor Concentrate During ECMO Support

NCT03613584 ↗

Phase 2 Unknown 68 enrolled Tirol Kiniken GmbH LFB BIOMEDICAMENTS · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

During treatments with extracorporeal circuits such as extracorporeal membrane oxygenation (ECMO) degradation of high molecular weight (HMW) of von Willebrand factor (vWF) multimers occur leading to an acquired von Willebrand disease. This disease is associated with increased bleeding and requirement for the transfusion with allogenic blood products especially packed red blood cells (PRBCs). A continuous treatment with von Willebrand factor concentrate (vWFC) may restore the multimers and bleeding can be avoided. Therefore a randomized, double-blind, prospective, controlled, two-arm clinical trial was designed, comparing patients receiving vWFC versus placebo.

Timeline

Start
2018-04-16
Primary completion
2021-03-10
Completion
2021-03-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator VON WILLEBRAND FACTOR HUMAN Protein / enzyme biologic 50 iu/kg —