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

Recruiting

• Conditions: Arterial or Venous Thrombosis

• Registration Number: NCT06650826
• Lead Sponsor: Cardioangiologisches Centrum Bethanien

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2024-07-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-16
• Study First Submitted QC: 2024-10-18
• Last Update Submitted: 2024-10-18
• Study First Posted: 2024-10-21
• Last Update Posted: 2024-10-21
• Primary Completion: 2026-07
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of anti-platelet factor 4 antibodies in temporal connection with the occurrence of arterial and/or venous thrombosis	Day 1	Presence of anti-platelet factor 4 antibodies in temporal connection with the occurrence of arterial and/or venous thrombosis

Trial Locations

Locations (2)

Deutsches Herzzentrum der Charite (DHZC); 🇩🇪 Berlin, Germany

Cardioangiologisches Zentrum Bethanien (CCB); 🇩🇪 Frankfurt am Main, Germany