Acquired Von Willebrand Disease Clinical Trial
Official title:
A Double-blind, Placebo-controlled Pilot Trial to Investigate the Administration of Von Willebrand Factor Concentrate (Willfact®, LFB France) in Adult Patients During Extracorporeal Membrane Oxygenation
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.
Increased shear stress during mechanical circulatory support (MCS) by extracorporeal membrane
oxygenation (ECMO) and ventricular assist devices (VAD) can provoke premature degradation of
high molecular weight (HMW) of von Willebrand factor (vWF) multimers. In patients with
intractable cardiac and/or respiratory failure requiring emergency ECMO support, the
investigators recently demonstrated an essential decrease in high molecular weight (HMW) vWF
multimer bands 24 and 48 hours after initiation of ECMO compared to baseline. Blood loss and
transfusion requirement during and shortly after ECMO support may be strengthened by loss of
HMW vWF multimers.
Administration of vWF concentrates may support restoration of primary hemostasis in patients
during ECMO support. Consequently the need for packed red blood cells (PRBCs) during ECMO
support may be reduced thus positively influencing morbidity and mortality of ECMO patients.
The investigators hypothesize, that treatment with vWF concentrate reduces the need for PRBCs
during ECMO support. Therefore the primary aim of this clinical trial is to find out if the
need of PRBCs differs in the group receiving a von Willebrand factor concentrate (vWFC), or
the placebo group (saline).
This clinical trial is planned as a randomized, double-blind, prospective, controlled,
two-arm, two-center study. Patients with intractable cardiac and/or respiratory failure
requiring emergency ECMO support undergoing surgery (Department of Anaesthesiology and
Intensive Care Medicine) or treated at the General and Surgical Intensive Care Unit (ACI),
Traumatologic Intensive Care Unit (TICU), Cardiologic Intensive Care Unit (CCU) or the ICU of
the Department of Visceral, Transplant and Thoracic Surgery at the Hospital Innsbruck (Tirol
Kliniken GmbH), Austria will be enrolled in the study when meeting the inclusion- and
exclusion criteria. If a patient meets the inclusion criteria and is recruited for the study,
the patient will be randomized either to the group receiving vWFC or placebo S. Before the
implementation of the ECMO the Baseline investigations need to be conducted. As soon as they
are completed the ECMO cannula can be inserted.
The administration of the Investigational Medicinal Product (IMP) will be start within 24h
after ECMO installation. Directly before IMP-start blood samples (Visit 2) will be drawn.
After 24h (Visit 3), 60h (Visit 4) and on day 5 (Visit 5) of the start of the study
medication visits will be conducted, whereas on day 5 (Visit 5) no special laboratory
(measurement of HMW vWF) will be analyzed. If ECMO can be terminated, a visit (Visit 6)
directly before the stop of the ECMO will be conducted. 36 h after the termination of the
ECMO Visit 7 (termination) will be performed. If the ECMO is needed longer than 7 days, the
administration of the IMP will be stopped on day 7 and a visit after 36 hours of IMP-stop
will be done for safety reasons but without special laboratory. After 30 days an interview
will be performed with the treating physician.
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