Collection of the Thrombo-VaxCov Cohort | NCT04889326

Studies
Collection of the Thrombo-VaxCov Cohort

NCT04889326

Sponsor

University Hospital, Lille

Status

Withdrawn

Last Update Posted

May 22, 2026Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Covid19
SARS-CoV Infection
Venous Thrombosis
Thrombocytopenia
Vaccination; Complications

Interventions

Retrospective data and biological samples

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID

Expanded Access Info

Start Date

Apr 2, 2021Actual

Primary Completion Date

May 1, 2023Actual

Completion Date

May 1, 2023Actual

First Submitted Date

Apr 27, 2021

First Submission Date that Met QC Criteria

May 11, 2021

First Posted Date

May 17, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2026

Last Update Posted Date

May 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patient hospitalized with atypical thrombosis within 4 weeks of anti-covid vaccination			Other: Retrospective data and biological samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Retrospective data and biological samples	Other	Analysis of data and biological samples collected during hospitalization:	patient hospitalized with atypical thrombosis within 4 weeks of anti-covid vaccination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional outcome (modified rankin scale)		through study completion, an average of 1 years

Secondary Outcomes

Measure	Description	Time Frame
Recurrent vascular events		through study completion, an average of 1 years
Mortality		through study completion, an average of 1 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

atypical thrombosis symptoms onset within 4 weeks of vaccination

Exclusion Criteria:

children

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charlotte Cordonnier, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU lille		Lille		59037	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D045169	Severe Acute Respiratory Syndrome
D020246	Venous Thrombosis
D013921	Thrombocytopenia

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided