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COVID-19 Associated Coagulopathy in Egypt

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ClinicalTrials.gov Identifier: NCT04507230
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Azza Abdelaal, Assiut University

Study Description
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Brief Summary:
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 commonly 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 (DIC) compared to 0.6% of survivors.

Condition or disease
Coagulopathy

Detailed Description:
studying the detailed coagulation screen and second line coagulation parameters including both thrombophilia screen and other acute phase coagulation factors.
Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessment of COVID-19 Associated Coagulopathy and Hypercoagulable State in Upper Egypt
Actual Study Start Date : August 7, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Coagulation screen [ Time Frame: 1 month ]
    Full coagulation screen

  2. Thrombophilia screen [ Time Frame: 1 month ]
    Full thrombophilia screen

  3. VWF, FVIII [ Time Frame: 1 month ]
    VWFAg, FVIII


Eligibility Criteria
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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

COVID 19 positive by RT- PCR who are admitted to Assiut University hospitals, Egypt.

Age and sex matched controls

Criteria

Inclusion Criteria:

  • patients with COVID 19 positive by RT- PCR

Exclusion Criteria:

  • no exclusions
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): NCT04507230


Contacts
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Contact: Azza Abdelaal, MD, PhD +201060033313 azzaabdelaal@aun.edu.eg
Contact: Hanan Galal, MD, PhD +201062226610 hanangalal2000@yahoo.com

Locations
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Egypt
Assiut University Hospitals Recruiting
Assiut, Egypt, 71515
Contact: Azza Ezzeldin, MD,PhD    +201001918207    azzam80@hotmail.com   
Sponsors and Collaborators
Assiut University
More Information
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Additional Information:

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Responsible Party: Azza Abdelaal, lecturer of clinical pathology, Assiut University
ClinicalTrials.gov Identifier: NCT04507230    
Other Study ID Numbers: 17300413
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 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 Azza Abdelaal, Assiut University:
hypercoagulable
COVID-19
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
 Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders