Study of Platelet Transfusion with Wilate Compared to Placebo to Reduce Blood Loss and Transfusion Needs in Bleeding ICU Patients

What this Trial Is About

This research aims to evaluate whether a high-normal dose of Wilate, a balanced mix of von Willebrand Factor vWF and coagulation factor VIII, can reduce blood loss and the need for transfusions in patients experiencing severe bleeding. The study focuses on patients who require platelet transfusion during or after surgery, comparing Wilate combined with platelets to a placebo combined with platelets. The trial is randomized and triple-blinded, conducted by the University Hospital in Basel, Switzerland. Participants receive either Wilate, which contains equal parts of vWF and factor VIII and is derived from plasma, or a placebo, both administered alongside platelet transfusions in cases of severe bleeding. The study examines whether adding Wilate enhances the clotting effect of platelets and reduces the overall need for transfusion products like platelet concentrates. This trial is designed to address situations where bleeding is severe and platelet counts or vWF activity may be low, such as during heart surgery or extracorporeal membrane oxygenation ECMO. During the study, participants are monitored closely for the amount of blood products used within 48 hours after treatment. Researchers will assess the reduction in transfusion needs and other outcomes like length of hospital stay and mortality. The study includes adult patients admitted to intensive care units who need platelet transfusions, with safety monitored throughout. Participation lasts until primary outcomes are measured, with detailed monitoring to gather data on treatment effects and patient outcomes.

Enhancement of the Haemostatic Effect of Platelets in the Presence of High Normal Concentrations of Von Willebrand Factor