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

Completed
Conditions
Antibodies Drug Specific
Thrombocytopenia
Registration Number
NCT06565364
Lead Sponsor
Medical University of Vienna
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
160
Inclusion Criteria
  • age ≥ 18 years
  • cardiac surgery on cardiopulmonary bypass
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Exclusion Criteria
  • cardiac surgery without cardiopulmonary bypass
  • age < 18 years
  • no written consent
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
prevalence of protamine/heparin antibodiespreoperatively until postoperative day 10
Secondary Outcome Measures
NameTimeMethod
Potential triggerspreoperatively

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

Clinical impactuntil 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

Trial Locations

Locations (1)

Medical University of Vienna

🇦🇹

Vienna, Austria

Medical University of Vienna
🇦🇹Vienna, Austria
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