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Thromboembolic Events in Severe COVID-19 Patients (COVICLOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04405869
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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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

Condition or disease
Pulmonary Thromboembolism

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Incidence of Thromboembolic Events and Prognosis of COVID-19 Patients Hospitalized in Intensive Care Units in France
Actual Study Start Date : April 29, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Analysis of incidence of thromboembolic events in patients with Sars-CoV-2 [ Time Frame: 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with a confirmed infection with the Sars-CoV-2 virus
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal of the patient to participate in data collection
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405869


Contacts
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Contact: Charles TACQUARD, MD 33 3 69 55 16 08 charlesambroise.tacquard@chru-strasbourg.fr
Contact: Saïd CHAYER, PhD, HDR 33 3 88 11 66 90 said.chayer@chru-strasbourg.fr

Locations
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France
Service d'Anesthésie-Réanimation - Nouvel Hôpital Civil Recruiting
Strasbourg, France, 67091
Contact: Charles TACQUARD, MD    33 3 69 55 16 08    charlesambroise.tacquard@chru-strasbourg.fr   
Sub-Investigator: Annick STEIB, MD, PhD         
Sub-Investigator: Anne Claude ROCHE, MD         
Sub-Investigator: Lea RYFFEL, MD         
Sub-Investigator: Isabelle GOUIN-THIBAULT, MD         
Sub-Investigator: Alexandre MANSOUR, MD         
Sub-Investigator: Alexandre GODON, MD         
Sub-Investigator: Pierre ALBALADEJO, MD, PhD         
Sub-Investigator: Anne GODIER, MD, PhD         
Sub-Investigator: Stephan MANKIKIAN, MD         
Sub-Investigator: Maxime NGUYEN SOENEN, MD         
Sub-Investigator: Bélaïd BOUHEMAD, MD, PhD         
Sub-Investigator: Sophie SUSEN, MD, PhD         
Sub-Investigator: Delphine GARRIGUE, MD         
Sub-Investigator: Julien POISSY, MD, PhD         
Sub-Investigator: Eric KIPNIS, MD, PhD         
Sub-Investigator: Cécile AUBRON, MD, PhD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04405869    
Other Study ID Numbers: 7779
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Covid-19
Thrombosis
D-Dimers
Anticoagulation
Additional relevant MeSH terms:
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Pulmonary Embolism
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Embolism