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Completed

NCT Number: NCT06565364

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

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.

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Key information

Conditions

Thrombocytopenia Antibodies Drug Specific Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥ 18 years
  • cardiac surgery on cardiopulmonary bypass

Exclusion criteria

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

Treatment and study plan

"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.

Primary outcomes

  1. prevalence of protamine/heparin antibodies

    Time frame: preoperatively until postoperative day 10

Secondary outcomes

  1. Potential triggers

    Time frame: 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

  2. Clinical impact

    Time frame: 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 outcomes

  1. Thrombin generation

    Time frame: preoperatively until postoperative day 6

    measurement of thrombin generation in a reduced number of participants

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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