The influence of the medication Willfact on the blood loss of patient during the use of a heart-lung machine

Phase 1

Conditions: Von Willebrand Disease (VWD)
MedDRA version: 19.1Level: PTClassification code 10069495Term: Acquired Von Willebrand's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disorders
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2016-000789-53-AT

Lead Sponsor: Medizinische Universität Innsbruck / Univ.-Klinik für Allgemeine und Chirurgische Intensivmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Patients with the need of veno-arterial or veno-venous ECMO for a minimum of 48 hours
- Age = 18 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: transfusion requirement of PRBC;Secondary Objective: - transfusion requirements of other allogenic blood products<br>- requirements of coagulation factor concentrates<br>- assessment of loss and restauration of vWF-HMW multimers <br>- assessment of the coagulation status <br>- changes in blood count, blood chemistry and blood gas<br>- platelet function <br>- kidney function<br>- bleeding score <br>- bleeding complications<br>- thromboembolic complications<br>- renal failure<br>- cardiovascular failure<br>- infections<br>- morbidity<br>- mortality<br><br>;Primary end point(s): - difference in the number red blood cells concentrates between the treatment arms per day ;Timepoint(s) of evaluation of this end point: - from the start of IMP (24h after ECMO installation) every full 24 hours

Secondary Outcome Measures