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

NCT ID: NCT06565364

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-07

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thrombocytopenia Antibodies Drug Specific

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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"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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* age ≥ 18 years
* cardiac surgery on cardiopulmonary bypass

Exclusion Criteria

* cardiac surgery without cardiopulmonary bypass
* age \< 18 years
* no written consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Caroline Holaubek, MD

Medical Doctor, Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara Steinlechner, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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EK Nr: 1895/2014

Identifier Type: -

Identifier Source: org_study_id

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