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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Determination of anti-platelet factor 4 antibodies in the blood.
- Who it may be relevant to
- Registry conditions: Arterial or Venous Thrombosis. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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 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
Primary outcome measures
- Presence of anti-platelet factor 4 antibodies in temporal connection with the occurrence of arterial and/or venous thrombosis [Time frame: Day 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Germany · 2 centers
- Deutsches Herzzentrum der Charite (DHZC) — Berlin
- Cardioangiologisches Zentrum Bethanien (CCB) — Frankfurt am Main
Identifiers
NCT: NCT06650826 · APIT