Immunogenicity and Thrombotic Potential of Circulating Protamine-heparin Complexes in Cardiac Surgery Patients

Medical University of Vienna160 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Thrombocytopenia Antibodies Drug Specific

Interventions

"ZYMUTEST™ 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age ≥ 18 years * cardiac surgery on cardiopulmonary bypass Exclusion Criteria: * cardiac surgery without cardiopulmonary bypass * age \< 18 years * no written consent

Locations (1)

Medical University of Vienna

Vienna, Austria

Outcomes

Primary Outcomes

prevalence of protamine/heparin antibodies

Time frame: preoperatively until postoperative day 10

Secondary Outcomes

Potential triggers

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

Time frame: preoperatively

Clinical impact

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

Time frame: until postoperative day 10

Data from ClinicalTrials.gov

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