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Evaluation of Coagulopathy in Critically Ill COVID-19 Patients.

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04479280
Recruitment Status : Completed
First Posted : July 21, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Azza Abdelaal, Assiut University

Brief Summary:

Novel coronavirus disease 19 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), this pneumonia was first emerged in December 2019 in Wuhan, China and rapidly spread around the world .

Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and is associated with increased mortality and admission to critical care. Most observed coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive hospitalization reported to have developed disseminated intravascular coagulation


Condition or disease Intervention/treatment
Coagulation Disorder Device: Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of the Role of Sonoclot Signature in Assessment of Coagulopathy in Critically Ill COVID 19 Patients
Actual Study Start Date : July 20, 2020
Actual Primary Completion Date : August 16, 2020
Actual Study Completion Date : August 16, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Covid19 positive patients Device: Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA
studying coagulation disorders in COVID19 critically ill patients

Covid19 negative patients Device: Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA
studying coagulation disorders in COVID19 critically ill patients




Primary Outcome Measures :
  1. clot rate formation [ Time Frame: 30 minutes ]
    measuring how rapid the sample will get clotted



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients who are suspected to be COVID 19 infection
Criteria

Inclusion Criteria:

  • COVID 19 critically ill patients

Exclusion Criteria:

  • any critical illness not related to COVID 19

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): NCT04479280


Locations
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Egypt
Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
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Responsible Party: Azza Abdelaal, lecturer of clinical pathology, Assiut University
ClinicalTrials.gov Identifier: NCT04479280    
Other Study ID Numbers: 17300446
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders