Study Regarding the Incidence of Anti-platelet Factor 4-antibodies in Patients Aged 18 to 60 Years With Spontaneous or Infection- or Vaccine-associated or Recurrent Venous and/or Arterial Thrombosis
NCT ID: NCT06650826
Last Updated: 2024-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2024-07-01
2027-01-31
Brief Summary
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Detailed Description
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As a secondary objective, platelet count, D-dimer and results of a thrombophilia screening as well as thrombosis localization are recorded.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Spontaneous arterial and/or venous thrombosis
Patients with spontaneous arterial and/or venous thrombosis
Determination of anti-platelet factor 4 antibodies in the blood
The anti-platelet factor 4 antibodies in the blood are determined using latex agglutination and the chemiluminescence method in the coagulation laboratory of the CCB MVZ laboratory. In addition, the platelet factor 4-induced platelet activation test (PIPA test) and the heparin-induced platelet activation test (HIPA test) as well as an ELISA-based platelet factor 4 IgG antibody test (Prof. Greinacher, Greifswald University Hospital) will be performed as part of the routine work up.
In addition a new assay for heparin-independent anti-PF4 antibody detection provided by the company Werfen using chemiluminescence will be performed.
Infection-associated arterial and/or venous thrombosis
Patients with infection-associated arterial and/or venous thrombosis
Determination of anti-platelet factor 4 antibodies in the blood
The anti-platelet factor 4 antibodies in the blood are determined using latex agglutination and the chemiluminescence method in the coagulation laboratory of the CCB MVZ laboratory. In addition, the platelet factor 4-induced platelet activation test (PIPA test) and the heparin-induced platelet activation test (HIPA test) as well as an ELISA-based platelet factor 4 IgG antibody test (Prof. Greinacher, Greifswald University Hospital) will be performed as part of the routine work up.
In addition a new assay for heparin-independent anti-PF4 antibody detection provided by the company Werfen using chemiluminescence will be performed.
Vaccine-associated arterial and/or venous thrombosis
Patients with vaccine-associated arterial and/or venous thrombosis
Determination of anti-platelet factor 4 antibodies in the blood
The anti-platelet factor 4 antibodies in the blood are determined using latex agglutination and the chemiluminescence method in the coagulation laboratory of the CCB MVZ laboratory. In addition, the platelet factor 4-induced platelet activation test (PIPA test) and the heparin-induced platelet activation test (HIPA test) as well as an ELISA-based platelet factor 4 IgG antibody test (Prof. Greinacher, Greifswald University Hospital) will be performed as part of the routine work up.
In addition a new assay for heparin-independent anti-PF4 antibody detection provided by the company Werfen using chemiluminescence will be performed.
Recurrent arterial and/or venous thrombosis despite anticoagulant therapy
Patients with recurrent arterial and/or venous thrombosis despite anticoagulant therapy
Determination of anti-platelet factor 4 antibodies in the blood
The anti-platelet factor 4 antibodies in the blood are determined using latex agglutination and the chemiluminescence method in the coagulation laboratory of the CCB MVZ laboratory. In addition, the platelet factor 4-induced platelet activation test (PIPA test) and the heparin-induced platelet activation test (HIPA test) as well as an ELISA-based platelet factor 4 IgG antibody test (Prof. Greinacher, Greifswald University Hospital) will be performed as part of the routine work up.
In addition a new assay for heparin-independent anti-PF4 antibody detection provided by the company Werfen using chemiluminescence will be performed.
Interventions
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Determination of anti-platelet factor 4 antibodies in the blood
The anti-platelet factor 4 antibodies in the blood are determined using latex agglutination and the chemiluminescence method in the coagulation laboratory of the CCB MVZ laboratory. In addition, the platelet factor 4-induced platelet activation test (PIPA test) and the heparin-induced platelet activation test (HIPA test) as well as an ELISA-based platelet factor 4 IgG antibody test (Prof. Greinacher, Greifswald University Hospital) will be performed as part of the routine work up.
In addition a new assay for heparin-independent anti-PF4 antibody detection provided by the company Werfen using chemiluminescence will be performed.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent of the patient
* Spontaneous arterial and/or venous thrombosis
* infection-associated arterial and/or venous thrombosis within 30 days of infection
* Vaccine-associated arterial and/or venous thrombosis within 30 days of vaccination
* Recurrent arterial or venous thrombosis despite anticoagulant therapy
Exclusion Criteria
* Risk-associated venous thromboses (e.g. following surgery, immobilization, plaster cast, fractures or sprains)
* Risk-associated arterial thromboses (in the presence of vascular risk factors such e.g. diabetes mellitus, hypercholesterolemia, hypertension, nicotine abuse)
* Thromboses more than 120 days old at the time of blood sampling
18 Years
60 Years
ALL
No
Sponsors
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Cardioangiologisches Centrum Bethanien
OTHER
Responsible Party
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Prof. Dr. med. E. Lindhoff-Last
Clinical Professor
Principal Investigators
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Edelgard Lindhoff-Last, Professor
Role: PRINCIPAL_INVESTIGATOR
Cardioangiologisches Zentrum Bethanien
Locations
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Deutsches Herzzentrum der Charite (DHZC)
Berlin, , Germany
Cardioangiologisches Zentrum Bethanien (CCB)
Frankfurt am Main, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APIT
Identifier Type: -
Identifier Source: org_study_id
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