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

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

Study Overview

• Status: Recruiting
• Conditions: Arterial or Venous Thrombosis
• Intervention / Treatment: Diagnostic test: Determination of anti-platelet factor 4 antibodies in the blood

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Edelgard Lindhoff-Last, Professor; Phone Number: +49-699450280; Email: e.lindhoff-last@ccb.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Not yet recruiting
    • Deutsches Herzzentrum der Charité (DHZC)
    • Contact: Jana Last, MD; Phone Number: +4930450513142; Email: jana_last@gmx.de
  • Frankfurt am Main, Germany, 60389
    • Recruiting
    • Cardioangiologisches Zentrum Bethanien (CCB)
    • Contact: Edelgard Lindhoff-Last, Professor; Phone Number: +49-699450280; Email: e.lindhoff-last@ccb.de
    • Principal Investigator: Edelgard Lindhoff-Last, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with venous and/or arterial thromboses that occur spontaneously, in association with infections or vaccinations or recurrently and are not associated with the presence of typical risk factors.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Spontaneous arterial and/or venous thrombosis; Patients with spontaneous arterial and/or venous thrombosis	Diagnostic test: Determination 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.
Infection-associated arterial and/or venous thrombosis; Patients with infection-associated arterial and/or venous thrombosis	Diagnostic test: Determination 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.
Vaccine-associated arterial and/or venous thrombosis; Patients with vaccine-associated arterial and/or venous thrombosis	Diagnostic test: Determination 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.
Recurrent arterial and/or venous thrombosis despite anticoagulant therapy; Patients with recurrent arterial and/or venous thrombosis despite anticoagulant therapy	Diagnostic test: Determination 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of anti-platelet factor 4 antibodies in temporal connection with the occurrence of arterial and/or venous thrombosis	Presence of anti-platelet factor 4 antibodies in temporal connection with the occurrence of arterial and/or venous thrombosis	Day 1

Collaborators and Investigators

• Sponsor: Cardioangiologisches Centrum Bethanien
• Investigators: Principal Investigator: Edelgard Lindhoff-Last, Professor, Cardioangiologisches Zentrum Bethanien

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: infections; vaccination; Anti-PF4 antibodies
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Physiological Effects of Drugs; Immunologic Factors; Coagulants; Antibodies; Platelet Factor 4
• Other Study ID Numbers: APIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No