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Prospective investigation of the incidence of anti-platelet factor 4 antibodies in suspected immune-associated arterial and/or venous thrombosis
Patients with venous and/or arterial thrombosis aged 18 to 60 years are included.Thromboses should have occurred spontaneously or within 30 days after an infection or vaccination. In addition, patients with recurrent thrombosis, despite anticoagulation, are also included in the study. The primary aim of the study is to determine the incidence of anti-platelet factor 4 antibodies in relation to venous and/or arterial thrombosis. For this purpose, we will take a blood sample from the patients within 120 days of the occurrence of the thrombosis.
As a secondary objective, platelet count, D-dimer and results of a thrombophilia screening as well as thrombosis localization are recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spontaneous arterial and/or venous thrombosis | Patients with spontaneous arterial and/or venous thrombosis |
| |
| Infection-associated arterial and/or venous thrombosis | Patients with infection-associated arterial and/or venous thrombosis |
| |
| Vaccine-associated arterial and/or venous thrombosis | Patients with vaccine-associated arterial and/or venous thrombosis |
| |
| Recurrent arterial and/or venous thrombosis despite anticoagulant therapy | Patients with recurrent arterial and/or venous thrombosis despite anticoagulant therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Determination of anti-platelet factor 4 antibodies in the blood | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of anti-platelet factor 4 antibodies in temporal connection with the occurrence of arterial and/or venous thrombosis | Presence of anti-platelet factor 4 antibodies in temporal connection with the occurrence of arterial and/or venous thrombosis | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with venous and/or arterial thromboses that occur spontaneously, in association with infections or vaccinations or recurrently and are not associated with the presence of typical risk factors.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edelgard Lindhoff-Last, Professor | Contact | +49-699450280 | e.lindhoff-last@ccb.de |
| Name | Affiliation | Role |
|---|---|---|
| Edelgard Lindhoff-Last, Professor | Cardioangiologisches Zentrum Bethanien | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum der Charite (DHZC) | Not yet recruiting | Berlin | 10117 | Germany |
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Blood samples kept at -80°C.
|
| Cardioangiologisches Zentrum Bethanien (CCB) | Recruiting | Frankfurt am Main | 60389 | Germany |
|
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D007239 | Infections |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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