Immunogenicity and Thrombotic Potential of Circulating Protamine-heparin Complexes in Cardiac Surgery Patients
- Conditions
- Antibodies Drug SpecificThrombocytopenia
- 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
- age ≥ 18 years
- cardiac surgery on cardiopulmonary bypass
- cardiac surgery without cardiopulmonary bypass
- age < 18 years
- no written consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method prevalence of protamine/heparin antibodies preoperatively until postoperative day 10
- Secondary Outcome Measures
Name Time Method Potential triggers 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 vasectomyClinical impact 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
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Vienna, Austria
Medical University of Vienna🇦🇹Vienna, Austria