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

August 20, 2024 updated by: Caroline Holaubek, MD, Medical University of Vienna

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

160 patients were included to the study with written informed consent. 4 patients did not undergo the planned surgical procedure due to medical reasons and therefore had to be excluded subsequently.

Description

Inclusion Criteria:

  • age ≥ 18 years
  • cardiac surgery on cardiopulmonary bypass

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prevalence of protamine/heparin antibodies
Time Frame: preoperatively until postoperative day 10
preoperatively until postoperative day 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
preoperatively
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
until postoperative day 10

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thrombin generation
Time Frame: preoperatively until postoperative day 6
measurement of thrombin generation in a reduced number of participants
preoperatively until postoperative day 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2019

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK Nr: 1895/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to an ongoing Doctor of Philosophy (PhD) Thesis the dataset is not available at the moment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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