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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 15 October 2018
Main ID:  EUCTR2017-003036-37-AT
Date of registration: 14/09/2017
Prospective Registration: Yes
Primary sponsor: Tirol Kliniken GmbH
Public title: The influence of the medication Willfact on the blood loss of patient during the use of a heart-lung machine
Scientific 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 - Von Willebrand factor concentrate during ECMO support
Date of first enrolment: 27/10/2017
Target sample size: 68
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003036-37
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Austria
Contacts
Name: Projektmanagement   
Address:  Anichstrasse 35 6020 Innsbruck Austria
Telephone: 004351250480451
Email: mirjam.bachler@tirol-kliniken.at
Affiliation:  Tirol Kliniken GmbH / Allgemeine und Chirurgische Intensivmedizin
Name: Projektmanagement   
Address:  Anichstrasse 35 6020 Innsbruck Austria
Telephone: 004351250480451
Email: mirjam.bachler@tirol-kliniken.at
Affiliation:  Tirol Kliniken GmbH / Allgemeine und Chirurgische Intensivmedizin
Key inclusion & exclusion 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:
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
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
Intervention(s)

Trade Name: Willfact
Product Name: Willfact
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: von Willebrand Faktor
CAS Number: 109319-16-6
Other descriptive name: VON WILLEBRAND FACTOR
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1000-

Trade Name: Physiologische Kochsalzlösung "Fresenius" - Infusionslösung
Product Name: Physiologische Kochsalzlösung "Fresenius" - Infusionslösung
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Natriumchlorid 0,9 %
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Concentration unit: g/l gram(s)/litre
Concentration type: equal
Concentration number: 9.0-

Trade Name: Willfact
Product Name: Willfact
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: von Willebrand Faktor
CAS Number: 109319-16-6
Other descriptive name: VON WILLEBRAND FACTOR
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 500-

Trade Name: Willfact
Product Name: Willfact
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: von Willebrand Faktor
CAS Number: 109319-16-6
Other descriptive name: VON WILLEBRAND FACTOR
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 2000-

Primary Outcome(s)
Main Objective: transfusion requirement of PRBC
Primary end point(s): - difference in the number red blood cells concentrates between the treatment arms per day
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
Timepoint(s) of evaluation of this end point: - from the start of IMP (24h after ECMO installation) every full 24 hours
Secondary Outcome(s)
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
Secondary ID(s)
ECMO-vWFC
Source(s) of Monetary Support
LFB Biomedicaments
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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