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

NCT06565364 | Completed

• 1 other identifier: EK Nr: 1895/2014
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Thrombocytopenia; Antibodies Drug Specific

Keywords

Thrombin generation; Protamine

Outcome Measures

Primary Outcomes (1)

• prevalence of protamine/heparin antibodies

  preoperatively until postoperative day 10

Secondary Outcomes (2)

• Potential triggers

  preoperatively

• Clinical impact

  until postoperative day 10

Other Outcomes (1)

• Thrombin generation

  preoperatively until postoperative day 6

Interventions

"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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• age ≥ 18 years
• cardiac surgery on cardiopulmonary bypass

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Barbara Steinlechner, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Research Fellow

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 21, 2024
• Study Start: January 7, 2019
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)