D69.53
Conditions
Interventions
Group 1: Participants: Patients who are scheduled for treatment with veno-venous (vv) extracorporeal membrane oxygenation (ECMO) due to respiratory failure / acute respiratory distress syndrome (ARDS)
Sponsors
Universitätsklinikum Tübingen
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Male and female patients =18 years undergoing treatment with ECC and cardiac support systems (ECMO = extracorporeal membrane oxygenation / / LVAD = left ventricular assist devices) due to cardiac failure, or lung failure, or a combination of these diseases.
Exclusion criteria
Exclusion criteria: 1. History of previously diagnosed hereditary coagulation and/or platelet disorders. 2. History of heparin-induced thrombocytopenia 3. Blood sampling for study purposes at less than three time points during the study 4. Participation in other clinical research studies involving evaluation of other investigational drugs or devices within 30 days of randomization 5. Diagnosis of hepatitis B, hepatitis C, and HIV. 6. Age < 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HIT (heparin-induced thrombocytopenia) incidence assessed using the 4 Ts score and three laboratory assays: rapid assay (Gel centrifugations assay. Lateral flow assay), PF4/Heparin ELISA and “Heparin-Induced Platelet Aggregation” (“HIPA”) test. These analyses will be performed on the day of implantation of the respective support device (before implantation), one day later, and on days 6 and 10 after implantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Activation and interaction of platelets and leukocytes assessed using flow cytometry. These analyses will be performed on the day of implantation of the respective support device (before implantation), one day later, and on days 6 and 10 after implantation. | — |
Countries
Germany
Contacts
Public ContactAndreas Straub
Universitätsklinik für Anaesthesiologie und Intensivmedizin Tübingen
Outcome results
None listed