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 Bethanien200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Arterial or Venous Thrombosis

Interventions

Determination of anti-platelet factor 4 antibodies in the bloodDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

Deutsches Herzzentrum der Charite (DHZC)

Berlin, Germany

NOT_YET_RECRUITING

Cardioangiologisches Zentrum Bethanien (CCB)

Frankfurt am Main, Germany

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Day 1

Central Contacts

Edelgard Lindhoff-Last, Professor

CONTACT

+49-699450280 e.lindhoff-last@ccb.de

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.