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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05075928
Other study ID # 7861
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date November 2021

Study information

Verified date October 2021
Source University Hospital, Strasbourg, France
Contact Anne-Sophie Korganow, MD, PhD
Phone 33 3 69 55 05 21
Email Anne-sophie.Korganow@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

SARS-COV-2 infection is responsible for a potentially severe primarily respiratory infection called COVID19. A large proportion of patients, in particular in severe forms, present with thrombotic manifestations (DVT, EP, stroke, thrombosis of dialysis circuits, etc.). A significant proportion is also a carrier of circulating anticoagulant (ACC or LA), making it possible to suggest a diagnosis of APS. This type of autoantibody results in a spontaneous prolongation of the TCA uncorrected by a control serum therefore is quickly diagnosed using standard hemostasis The objective of this study is to describe the diagnosis of thrombotic complications in COVID19 patients presenting a positive lupus anticoagulant type test (LA) or aPL and the associated clinical and biological elements that may have favored thrombosis.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date November 2021
Est. primary completion date November 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Adult patient (=18 years old) - Patient taken care of in the SMO pole or the NHC surgical resuscitation service or hospitalized or consultant to the HUS between 01/03/2020 and 31/05/2020 - Patient infected with Covid-19, with a documented infection, having presented a documented thrombosis (arterial or venous), with an LA or aPL in the thrombosis assessment - or Patient infected with Covid-19, with a documented infection, without documented thrombosis (arterial or venous), with in the standard work-up an increase in TCA revealing the presence of LA - Subject having given his agreement for the reuse of his data for the purposes of this research Exclusion criteria: - Subject having expressed opposition to participating in the study - Subject under guardianship or guardianship - Subject under safeguard of justice

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Service de Médecine Interne et d'Immunologie Clinique - Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retrospective study of thrombotic complications in a cohort of COVID patients with a circulating anticoagulant Files analysed retrospectively from March 01, 2020 to May 31, 2019 will be examined]
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