THROMBO-VAXCOV: Collection of the Thrombo-VaxCov Cohort
Sponsor
University Hospital, Lille (Other)
Overall Status
Recruiting
CT.gov ID
NCT04889326
Collaborator
(none)
100
1
24.9
4
Study Details
Study Description
Brief Summary
In the context of anti-Covid19 vaccination, atypical thrombosis have occured and potential link with vaccination is under investigation.
This study collect clinical and biological data of all atypical thrombosis occurring within 4 weeks after antiCovid vaccination.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
In the context of anti-Covid19 vaccination, atypical thrombosis have occurred and potential links with vaccination is under investigation. In France, the study collect clinical and biological data of all atypical thrombosis occurring within 4 weeks after anti-Covid vaccination.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Clinico-biological Database on Atypical Venous Thrombosis in the Context of anticovid19 Vaccination
Actual Study Start Date
:
Apr 2, 2021
Anticipated Primary Completion Date
:
May 1, 2023
Anticipated Study Completion Date
:
May 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| patient hospitalized with atypical thrombosis within 4 weeks of anti-covid vaccination
|
Other: Retrospective data and biological samples
Analysis of data and biological samples collected during hospitalization:
|
Outcome Measures
Primary Outcome Measures
- Functional outcome (modified rankin scale) [through study completion, an average of 1 years]
Secondary Outcome Measures
- Recurrent vascular events [through study completion, an average of 1 years]
- Mortality [through study completion, an average of 1 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
atypical thrombosis symptoms onset within 4 weeks of vaccination
Exclusion Criteria:
children
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU lille | Lille | France | 59037 |
Sponsors and Collaborators
- University Hospital, Lille
Investigators
- Principal Investigator: Charlotte Cordonnier, MD,PhD, University Hospital, Lille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT04889326
Other Study ID Numbers:
- ECH_2021_cb
First Posted:
May 17, 2021
Last Update Posted:
May 17, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: