Antibodies Drug Specific, Thrombocytopenia
Conditions
Keywords
Thrombin generation, Protamine
Brief 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.
Interventions
DIAGNOSTIC_TESTZYMUTEST™ 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.
Sponsors
Medical University of Vienna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* age ≥ 18 years * cardiac surgery on cardiopulmonary bypass
Exclusion criteria
* cardiac surgery without cardiopulmonary bypass * age \< 18 years * no written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| prevalence of protamine/heparin antibodies | preoperatively until postoperative day 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Potential triggers | preoperatively | The presence of the following conditions was evaluated preoperatively: * repeated surgery on cardiopulmonary bypass (CPB) * bleeding disorders * age in years * height in meters * weight in kilograms * weight and height will be combined to report the body-mass-index in kg/m\^2 * previous thromboembolic event * diabetes mellitus with/without insulin treatment * cardiac function and valve diseases * preoperative presence of peripheral artery disease * preoperative presence of renal diseases * fish allergy * men after vasectomy |
| Clinical impact | until postoperative day 10 | Information about the following events were collected until day 10 or discharge of the patients: * cardiovascular events: thrombosis, tachycardic atrial fibrillation, cardiopulmonary resuscitation * delay in platelet count recovery * difference in severity of thrombocytopenia (platelet count in 10\^9/l) * cerebrovascular events: stroke, seizure * kidney function: creatinine in mg/dl, urea in mg/dl, need for renal replacement therapy * inflammation parameters: white blood count in 10\^9/l, C-reactive protein in mg/dl |
Other
| Measure | Time frame | Description |
|---|---|---|
| Thrombin generation | preoperatively until postoperative day 6 | measurement of thrombin generation in a reduced number of participants |
Countries
Austria
Outcome results
None listed