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NCT Number: NCT06650826

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

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

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Deutsches Herzzentrum der Charite (DHZC), Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Determination of anti-platelet factor 4 antibodies in the blood

Diagnostic 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.

Primary outcomes

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

    Time frame: Day 1

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

Study contacts

Contact information is provided by the study sponsor or research team.

Edelgard Lindhoff-Last, Professor

CONTACT

[email protected]

+49-699450280

Sponsors and collaborators

Lead sponsor

Cardioangiologisches Centrum Bethanien

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 21, 2024
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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