NCT04405869

Brief Summary

The main objective of this study is to describe the incidence of thromboembolic events in a population of patients hospitalized in intensive care units in France for severe COVID-19. The secondary objective of this study is to describe the evolution of hemostasis parameters during the first two weeks of intensive care hospitalization and to evaluate the influence of different anticoagulation regimens on these parameters and on the incidence of thromboembolic events

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 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 29, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

11 months

First QC Date

May 25, 2020

Last Update Submit

May 27, 2020

Conditions

Keywords

Covid-19ThrombosisD-DimersAnticoagulation

Outcome Measures

Primary Outcomes (1)

  • Analysis of incidence of thromboembolic events in patients with Sars-CoV-2

    1 month

Eligibility Criteria

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

Patients with a confirmed infection with the Sars-CoV-2 virus

You may qualify if:

  • Confirmed infection with the Sars-CoV-2 virus (RT-PCR)
  • Hospitalization in Intensive Care Unit
  • Age over 18 years Old

You may not qualify if:

  • Refusal of the patient to participate in data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Anesthésie-Réanimation - Nouvel Hôpital Civil

Strasbourg, 67091, France

RECRUITING

Related Publications (1)

  • Tacquard C, Mansour A, Godon A, Godet J, Poissy J, Garrigue D, Kipnis E, Rym Hamada S, Mertes PM, Steib A, Ulliel-Roche M, Bouhemad B, Nguyen M, Reizine F, Gouin-Thibault I, Besse MC, Collercandy N, Mankikian S, Levy JH, Gruel Y, Albaladejo P, Susen S, Godier A; French Working Group on Perioperative Hemostasis. Impact of High-Dose Prophylactic Anticoagulation in Critically Ill Patients With COVID-19 Pneumonia. Chest. 2021 Jun;159(6):2417-2427. doi: 10.1016/j.chest.2021.01.017. Epub 2021 Jan 16.

MeSH Terms

Conditions

Pulmonary EmbolismCOVID-19Thrombosis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

May 25, 2020

First Posted

May 28, 2020

Study Start

April 29, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

May 29, 2020

Record last verified: 2020-05

Locations