- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04366752
Thrombo Embolic Events in Critical Care Patients With Covid-19 Serious Acute Pneumopathy (THROMBOCOVID)
The understanding of haemostasis and inflammation cross-talk has gained considerable knowledge during the past decade in the field of arterial and venous thrombosis. Complex and delicately balanced interaction between coagulation and inflammation involve all cellular and humoral components. Elements of the coagulation system such as activated thrombin, fibrinogen or factor Xa may increase inflammation by promoting the production of pro-inflammatory cytokines, chemokines, growth factors and adhesion molecules that lead to a procoagulant state amplifying the pathological process. Recent evidence supports inflammation as a common pathogenic contributor to both arterial and venous thrombosis, giving rise to the concept of inflammation-induced thrombosis.
Patients with infection of COVID-19 and severe pneumoniae seem to have higher risk of thromboembolism. Very few data are available regarding the biological disorders of coagulation in these patients. Th purpose of this project is to analyze hemostasis and coagulation of patients with infection of COVID-19 and severe pneumonia.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Amiens, France, 80480
- CHU Amiens
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients hospitalized in medical ICU with pneumonia due to COVID-19 infection
Exclusion Criteria:
- patients< 18 years
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variation of thrombin time (in secondes) in Covid-19 patients with pneumonia admitted in ICU.
Time Frame: up to 6 weeks
|
The reference range for the thrombin time is usually less than 20 seconds (ie, 15-19 seconds)
|
up to 6 weeks
|
Variation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
Time Frame: up to 6 weeks
|
Variation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
|
up to 6 weeks
|
Variation of factor II concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
Time Frame: up to 6 weeks
|
Variation of factor II concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
|
up to 6 weeks
|
Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Covid-19 patients with pneumonia admitted in ICU.
Time Frame: up to 6 weeks
|
Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Covid-19 patients with pneumonia admitted in ICU.
|
up to 6 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Lung Diseases
- Embolism and Thrombosis
- COVID-19
- Pneumonia
- Thromboembolism
Other Study ID Numbers
- PI2020_843_0036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
First Affiliated Hospital Xi'an Jiaotong UniversityShangluo Central Hospital; Ankang Central Hospital; Hanzhong Central Hospital; Yulin... and other collaboratorsRecruitingCOVID-19 | Post-COVID-19 Syndrome | Post-Acute COVID-19 | Acute COVID-19China
Clinical Trials on venous ultrasound
-
Lashmi VenkatraghavanUniversity Health Network, TorontoCompleted
-
Centre Antoine LacassagneCompletedCovid19 | Thromboembolism | Neoplasms MalignantFrance, Monaco
-
The University of Texas Medical Branch, GalvestonWithdrawnPregnancy | ObeseUnited States
-
University Hospital of PatrasCompletedPacemaker | Implantable Cardioverter-defibrillatorGreece
-
Mansoura UniversityRecruitingIntensive Care UnitEgypt
-
Massachusetts General HospitalNational Cancer Institute (NCI)Completed
-
University of ZurichUnknown
-
Region SkaneRecruitingHeart Failure | Cardiac Arrhythmia | AV BlockSweden
-
University Hospital of FerraraCompletedArrhythmias, Cardiac | Implantable Defibrillator User | Vascular Access Complication | Venous Puncture | Pacemaker Complication | Fluoroscopy; Adverse EffectItaly
-
Postgraduate Institute of Medical Education and...CompletedCompare Central Line Insertion of Subclavian Vein With Two Different Approaches Using Ultrasound