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

Cardioangiologisches Centrum Bethanien

Status: Enrolling

Conditions: Arterial or Venous Thrombosis

Treatments: Diagnostic Test: Determination of anti-platelet factor 4 antibodies in the blood

Study type: Observational

Funder types: Other

Identifiers

NCT06650826

APIT

Details and patient eligibility

About

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

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

200 participants in 4 patient groups

Spontaneous arterial and/or venous thrombosis

Description:

Patients with spontaneous arterial and/or venous thrombosis

Treatment:

Diagnostic Test: Determination of anti-platelet factor 4 antibodies in the blood

Infection-associated arterial and/or venous thrombosis

Description:

Patients with infection-associated arterial and/or venous thrombosis

Treatment:

Diagnostic Test: Determination of anti-platelet factor 4 antibodies in the blood

Vaccine-associated arterial and/or venous thrombosis

Description:

Patients with vaccine-associated arterial and/or venous thrombosis

Treatment:

Diagnostic Test: Determination of anti-platelet factor 4 antibodies in the blood

Recurrent arterial and/or venous thrombosis despite anticoagulant therapy

Description:

Patients with recurrent arterial and/or venous thrombosis despite anticoagulant therapy

Treatment:

Diagnostic Test: Determination of anti-platelet factor 4 antibodies in the blood