EUCTR2017-003036-37-AT
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Von Willebrand Disease (VWD)
- Sponsor
- Tirol Kliniken GmbH
- Enrollment
- 68
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Not specified
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