NCT04889326

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

2.1 years

First QC Date

April 27, 2021

Last Update Submit

January 17, 2023

Conditions

Covid19SARS-CoV InfectionVenous ThrombosisThrombocytopeniaVaccination; Complications

Outcome Measures

Primary Outcomes (1)

  • Functional outcome (modified rankin scale)

    through study completion, an average of 1 years

Secondary Outcomes (2)

  • Recurrent vascular events

    through study completion, an average of 1 years

  • Mortality

    through study completion, an average of 1 years

Study Arms (1)

patient hospitalized with atypical thrombosis within 4 weeks of anti-covid vaccination

Other: Retrospective data and biological samples

Interventions

Retrospective data and biological samplesOTHER

Analysis of data and biological samples collected during hospitalization:

patient hospitalized with atypical thrombosis within 4 weeks of anti-covid vaccination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patient hospitalized with atypical thrombosis occurring within 4 weeks of anticovid vaccination

You may qualify if:

  • atypical thrombosis symptoms onset within 4 weeks of vaccination

You may not qualify if:

  • children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory SyndromeVenous ThrombosisThrombocytopenia

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Study Officials

  • Charlotte Cordonnier, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Cordonnier, MD,PhD

CONTACT

0320445962charlotte.cordonnier@chru-lille.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2021

First Posted

May 17, 2021

Study Start

April 2, 2021

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

Locations

FR(1)