ThrombocytopeniaNCT06565364
Immunogenicity and Thrombotic Potential of Circulating Protamine-heparin Complexes in Cardiac Surgery Patients
An observational study of Thrombocytopenia and Antibodies Drug Specific, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Thrombocytopenia, Antibodies Drug Specific
- What is being tested?
- "ZYMUTEST™ HIA" immunoglobulin g ELISA (enzyme-linked immunosorbent assay )
- How many people
- 160 participants
- Where
- 1 siteAustria
- Study dates
- 7 Jan 2019to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- age ≥ 18 years
- cardiac surgery on cardiopulmonary bypass
Who cannot join
- cardiac surgery without cardiopulmonary bypass
- age < 18 years
- no written consent
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- "ZYMUTEST™ HIA" immunoglobulin g ELISA (enzyme-linked immunosorbent assay )
- Keywords
- Thrombin generation, Protamine
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"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.
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of protamine/heparin antibodies
Measured: preoperatively until postoperative day 10
Secondary outcomes (2)
Potential triggers
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
Measured: preoperatively
Clinical impact
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
Measured: until postoperative day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start7 Jan 2019
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Holaubek, MD, Medical University of Vienna
- Investigators
- Barbara Steinlechner, MD, Principal investigator, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565364
- Sponsor's protocol ID
- EK Nr: 1895/2014
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to an ongoing Doctor of Philosophy (PhD) Thesis the dataset is not available at the moment
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Thrombotic Potential of Circulating Protamine-heparin Complexes in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT06565364
- Acronym / sponsor ID
- EK Nr: 1895/2014
- Conditions
- Thrombocytopenia, Antibodies Drug Specific
- Keywords
- Thrombin generation, Protamine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- age ≥ 18 years
- cardiac surgery on cardiopulmonary bypass
Key exclusion criteria (3 listed)
- cardiac surgery without cardiopulmonary bypass
- age < 18 years
- no written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "ZYMUTEST™ HIA" immunoglobulin g ELISA (enzyme-linked immunosorbent assay )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. | Diagnostic test | – |
Primary outcome
prevalence of protamine/heparin antibodies
Time frame: preoperatively until postoperative day 10
2 secondary outcomes
Potential triggers
Time frame: preoperatively
Clinical impact
Time frame: until postoperative day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No. Due to an ongoing Doctor of Philosophy (PhD) Thesis the dataset is not available at the moment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Steinlechner, MD principal investigator
Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia and Antibodies Drug Specific, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of protamine/heparin antibodies (time frame: preoperatively until postoperative day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.