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

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2016-000789-53-AT
• Date of registration: 17/10/2016
• Prospective Registration: Yes
• Primary sponsor: Medizinische Universität Innsbruck / Univ.-Klinik für Allgemeine und Chirurgische Intensivmedizin
• 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 pilot trial to investigate the administration of von Willebrand factor concentrate (Willfact®, LFB France) in adult patients during extracorporeal membrane oxygenation - Willfact during ECMO
• Date of first enrolment: 09/03/2017
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000789-53
• 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
• Affiliation: Medizinische Universität Innsbruck / Univ.-Klinik für Allgemeine und Chirurgische Intensivmedizin

• Name: Projektmanagement
• Affiliation: Medizinische Universität Innsbruck / Univ.-Klinik für 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
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Von Willebrand Disease (VWD)
MedDRA version: 19.1 Level: PT Classification code 10069495 Term: Acquired Von Willebrand's disease System Organ Class: 10005329 - Blood and lymphatic system disorders

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

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)

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

Main Objective: transfusion requirement of PRBC

Timepoint(s) of evaluation of this end point: - from the start of IMP (24h after ECMO installation) every full 24 hours

Primary end point(s): - difference in the number red blood cells concentrates between the treatment arms per day

Secondary Outcome(s)

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 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

Secondary ID(s)

VWFC-ECMO

Source(s) of Monetary Support

LFB Biomedicaments