Sponsor study identifier
observational
160
1 country
1
Study Start
January 7, 2019
Actual (reported)Primary Completion
March 31, 2023
Actual (reported)Study Completion
March 31, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2023
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 7, 2019
Actual (reported)March 31, 2023
Actual (reported)March 31, 2023
Actual (reported)August 7, 2024
Actual (reported)August 21, 2024
Actual (reported)prevalence of protamine/heparin antibodies
preoperatively until postoperative day 10
Potential triggers
preoperatively
Clinical impact
until postoperative day 10
Thrombin generation
preoperatively until postoperative day 6
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Medical University of Vienna
Vienna, 1090, Austria
Barbara Steinlechner, MD
Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna
160 participants (actual enrollment reported by the registry).
First Submitted
August 7, 2024
First Posted
August 21, 2024
Study Start
January 7, 2019
Actual (reported)A Prospective, Open, Multicenter Clinical Trial of Eltrombopag Combined With Diacerein in Eltrombopag-inefficient or Relapsed ITP
Contact the study team to confirm eligibility.
Primary Completion
March 31, 2023
Actual (reported)Study Completion
March 31, 2023
Actual (reported)Last Updated
August 21, 2024
Record last verified: 2024-08
Due to an ongoing Doctor of Philosophy (PhD) Thesis the dataset is not available at the moment
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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