An observational study in Arterial or Venous Thrombosis, sponsored by Cardioangiologisches Centrum Bethanien. Recruiting at 2 sites in Germany. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-10-21.
Sponsored by Cardioangiologisches Centrum Bethanien · Observational
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.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's planned enrollment of 200 is close to the median of 213 across 586 observational studies indexed under Thrombosis.
Browse Thrombosis studies →Cardioangiologisches Centrum Bethanien is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients with spontaneous arterial and/or venous thrombosis
Diagnostic Test: Determination of anti-platelet factor 4 antibodies in the blood
Patients with infection-associated arterial and/or venous thrombosis
Diagnostic Test: Determination of anti-platelet factor 4 antibodies in the blood
Patients with vaccine-associated arterial and/or venous thrombosis
Diagnostic Test: Determination of anti-platelet factor 4 antibodies in the blood
Patients with recurrent arterial and/or venous thrombosis despite anticoagulant therapy
Diagnostic Test: 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.
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
Time frame: Day 1
Plan to share: No
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Cardioangiologisches Centrum Bethanien