NCT04359992

Brief Summary

The COVID-19 outbreak has led to a significant increase in the number of patients admitted to intensive care for respiratory distress. Early data indicate a particularly high risk of thrombotic risk to viral lung disease, particularly in the most severe patients, with a particularly high incidence of pulmonary embolism. Catheter thrombosis and extra-renal purification filters are also abnormally common. These thrombotic complications could contribute to the mortality observed in this pathology. The introduction of early curative anticoagulation in the most severe patients has just been proposed by the perioperative hemostasis interest group Biologically, a significant proportion of patients hospitalized in intensive care have a marked biological inflammatory syndrome, associated with signs of activation of clotting (a frank increase in D-dimers). The presence of circulating anticoagulants is common. Interestingly, thrombocytosis, normally observed in such inflammatory syndromes, is absent. In this context, it seems legitimate to explore these patients from a hemostasis perspective to identify the factors that cause this thrombotic over-risk, in order to minimize the occurrence of these complications.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

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

First Submitted

Initial submission to the registry

April 16, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

April 17, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

April 16, 2020

Last Update Submit

April 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Platelet activation intensity with the occurrence of clinical thrombotic complications

    Change of platelet activity from admission's day in intensive care unit to 2 days and 7 days

Interventions

3 extra blood samples at day 0, 2 and 7

Eligibility Criteria

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

Adult patients hospitalized in intensive care for severe COVID-19 infection

You may qualify if:

  • Adult patient (\<18y)
  • With a SARS-CoV-2 infection confirmed by RT-PCR
  • Hospitalized in intensive care

You may not qualify if:

  • Patients under guardianship/curator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tacquard C, Mouriaux C, Delabranche X, Bourdon C, Eckly A, Magnenat S, Sattler L, Gachet C, Mertes PM, Hechler B, Mangin PH. Platelet dysfunction and thrombus instability in flow conditions in patients with severe COVID-19. Thromb Res. 2023 Jan;221:137-148. doi: 10.1016/j.thromres.2022.11.004. Epub 2022 Nov 8.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 24, 2020

Study Start

April 17, 2020

Primary Completion

April 17, 2021

Study Completion

May 1, 2021

Last Updated

April 24, 2020

Record last verified: 2020-04