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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "ZYMUTESTâ„¢ HIA" immunoglobulin g ELISA (enzyme-linked immunosorbent assay ) | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| prevalence of protamine/heparin antibodies | preoperatively until postoperative day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Potential triggers | The presence of the following conditions was evaluated preoperatively:
|
| Measure | Description | Time Frame |
|---|---|---|
| Thrombin generation | measurement of thrombin generation in a reduced number of participants | preoperatively until postoperative day 6 |
Inclusion Criteria:
Exclusion Criteria:
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160 patients were included to the study with written informed consent. 4 patients did not undergo the planned surgical procedure due to medical reasons and therefore had to be excluded subsequently.
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Steinlechner, MD | Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | 1090 | Austria |
Due to an ongoing Doctor of Philosophy (PhD) Thesis the dataset is not available at the moment
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| preoperatively |
| Clinical impact | Information about the following events were collected until day 10 or discharge of the patients:
| until postoperative day 10 |
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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