Von Willebrand Disease (VWD) MedDRA version: 20.0 Level: PT Classification code 10069495 Term: Acquired Von Willebrand's disease System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Sponsors
Tirol Kliniken GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: - Patient with known thromboembolic event in the last 30 days - Inevitable lethal course - Quick < 30 % due to severe liver failure - Bleeding tendency (e.g. hemophilia) - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: transfusion requirement of PRBC;Secondary Objective: - transfusion requirements of other allogenic blood products - requirements of coagulation factor concentrates - assessment of loss and restauration of vWF-HMW multimers - assessment of the coagulation status - changes in blood count, blood chemistry and blood gas - platelet function - kidney function - bleeding score - bleeding complications - thromboembolic complications - renal failure - cardiovascular failure - infections - morbidity - mortality;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - difference in the number of other high risk allogenic transfusion products (fresh frozen plasma and platelet concentrate) between the treatment arms per day - amount of coagulation factor concentrates given during ECMO support between the treatment arms per day - measurement of vWF multimers, vWF:RCo ratio, vWF:Ag ratio, vWF:CB ratio, F:VIII, vWF-cleaving protease (ADAMTS-13) and collagen binding activity (CBA) - measurement of PT, aPTT, FXII, FXIII, Heparin/Argatroban-level, fibrinogen (Clauss + immune.), antithrombin, platelet count and ROTEM (InTEM, ExTEM, FibTEM) - difference in the blood count , chemical parameters and blood gas analysis over the ECMO period - difference in the platelet activation (multiplate: TRAP-test, ADP-test, Aspi-test, Risto-test) - daily urine output (every 24 h period) - difference in the bleeding scores (after Mazzeffi et al., 2013), SOFA, SAPSII und SAPS3 (first 24 h) - difference in the number of bleeding events - difference in the number of thromboembolic events - acute kidney injury, need for hemofiltration - location and type of infection - difference in the need of vasopressors and inotropics - MOD/MOF (SAPSIII, SOFA) - 30-day mortality;Timepoint(s) of evaluation of this end point: daily (every 24 hours) or at Visit time points: Visit 1: before ECMO installation Visit 2: before IMP start Visit 3: 24h after IMP start Visit 4: 60h after IMP start Visit 5: 5 days after IMP start Visit 6: before ECMO stop (this visit can replace Visit 3, 4 or 5 if ECMO stop is within the appropriate time window) Visit 7: 36h after ECMO stop Visit S: 36h after IMP stop if ECMO is needed longer than 7 days and is not the same as Visit 7 Visit vWF-AB: at hospital discharge or at an ambulatory after-care appointment Visit 8: Interview | — |
Countries
Austria
Contacts
Public ContactProjektmanagement
Tirol Kliniken GmbH / Allgemeine und Chirurgische Intensivmedizin
Outcome results
None listed