Trials / Completed
CompletedNCT06565364
Immunogenicity and Thrombotic Potential of Circulating Protamine-heparin Complexes in Cardiac Surgery Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 160 (actual)
- Sponsor
- Medical University of Vienna · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
The primary aim of this study was to describe the prevalence and time course of the occurrence of protamine/heparin antibodies in patients undergoing cardiac surgery on cardiopulmonary bypass. The second aim was to identify triggers of immunization. The third aim of this study was to evaluate a potential clinical impact of protamine/heparin antibodies and their platelet-activating properties leading to thromboembolism and other adverse outcomes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | "ZYMUTEST™ HIA" immunoglobulin g ELISA (enzyme-linked immunosorbent assay ) | The enzyme-linked immunosorbent assay is an in vitro test done in the laboratory to detect specific antibodies against heparin/platelet factor-4 and protamine/heparin complexes. |
Timeline
- Start date
- 2019-01-07
- Primary completion
- 2023-03-31
- Completion
- 2023-03-31
- First posted
- 2024-08-21
- Last updated
- 2024-08-21
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT06565364. Inclusion in this directory is not an endorsement.