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

NCT06650826 | Recruiting

• 1 other identifier: APIT
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Arterial or Venous Thrombosis

Keywords

Anti-PF4 antibodies; infections; vaccination

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

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

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

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

Interventions

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.

Infection-associated arterial and/or venous thrombosis; Recurrent arterial and/or venous thrombosis despite anticoagulant therapy; Spontaneous arterial and/or venous thrombosis; Vaccine-associated arterial and/or venous thrombosis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardioangiologisches Centrum Bethanien: lead

Study Sites (2)

Deutsches Herzzentrum der Charite (DHZC)

Berlin, 10117, Germany

NOT YET RECRUITING

Cardioangiologisches Zentrum Bethanien (CCB)

Frankfurt am Main, 60389, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples kept at -80°C.

MeSH Terms

Conditions

Venous Thrombosis; Infections

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Edelgard Lindhoff-Last, Professor

  Cardioangiologisches Zentrum Bethanien

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edelgard Lindhoff-Last, Professor

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 21, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)