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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06650826

Enrollment

200

Registered

2024-10-21

Start date

2024-07-01

Completion date

2027-01-31

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial or Venous Thrombosis

Keywords

Anti-PF4 antibodies, infections, vaccination

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.

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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Germany

Contacts

Primary ContactEdelgard Lindhoff-Last, Professor

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026