RecruitingNCT06650826

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

The APIT Study: Prospective Observational Study of the Incidence of Anti-platelet Factor 4 Antibodies in Suspected Immune-associated Arterial and/or Venous Thrombosis

Sponsor

Cardioangiologisches Centrum Bethanien

Enrollment

200 participants

Start Date

Jul 1, 2024

Study Type

OBSERVATIONAL

Conditions

Arterial or Venous Thrombosis

Summary

Prospective investigation of the incidence of anti-platelet factor 4 antibodies in suspected immune-associated arterial and/or venous thrombosis

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria6

Age between 18-60 years
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 Criteria4

Lack of consent of the patient
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

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Interventions

DIAGNOSTIC_TESTDetermination 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.

Locations(2)

Deutsches Herzzentrum der Charite (DHZC)

Berlin, Germany

Cardioangiologisches Zentrum Bethanien (CCB)

Frankfurt am Main, Germany

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NCT06650826