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

Medical University of Vienna

Status: Completed

Conditions: Thrombocytopenia; Antibodies Drug Specific

Treatments: Diagnostic Test: "ZYMUTEST™ HIA" immunoglobulin g ELISA (enzyme-linked immunosorbent assay )

Study type: Observational

Funder types: Other

Identifiers

NCT06565364

EK Nr: 1895/2014

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥ 18 years
• cardiac surgery on cardiopulmonary bypass

Exclusion criteria

• cardiac surgery without cardiopulmonary bypass
• age < 18 years
• no written consent