MedTrace Logo

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

NCT06565364 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2024-08-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Barbara Steinlechner, MD · Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06565364 on ClinicalTrials.gov