Von Willebrand Factor Concentrate During ECMO Support

• Status: Active, not recruiting
• Trial end date: 2021-03-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tirol Kiniken GmbH
• Collaborator: LFB BIOMEDICAMENTS
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Patients with the need of veno-arterial or veno-venous ECMO for a minimum of 48 hours

• Age ≥ 18 years

Exclusion Criteria:

• Patient with known thromboembolic event in the last 30 days

• Inevitable lethal course

• Severe Liver failure: Quick < 30 %

• Pregnancy

• Patient with known refusal of a participation in this clinical trial

• Active participation in another clinical trial

• Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study or confound the ability to interpret data from the study