Prospective study investigating the incidence of heparin-induced thrombocytopenia in patients treated with mechanical circulatory support
- Conditions
- D69.53
- Registration Number
- DRKS00014096
- Lead Sponsor
- niversitätsklinikum Tübingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 41
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
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>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 Outcome Measures
Name Time Method Activation and interaction of platelets and leukocytes assessed using flow cytometry.<br><br>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.