Evaluation of Coagulopathy in Critically Ill COVID-19 Patients.

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04479280
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Actual Duration (Days): 27
• Patients Per Site Per Month: 78.9

Study Details

Study Description

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	Phase
Coagulation Disorder	Device: Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA

Study Design

• 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: Jul 20, 2020
• Actual Primary Completion Date: Aug 16, 2020
• Actual Study Completion Date: Aug 16, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. clot rate formation [30 minutes]

   measuring how rapid the sample will get clotted

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• COVID 19 critically ill patients

Exclusion Criteria:

• any critical illness not related to COVID 19

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university	Assiut		Egypt	71111

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Azza Abdelaal, lecturer of clinical pathology, Assiut University
• ClinicalTrials.gov Identifier: NCT04479280
• Other Study ID Numbers: 17300446
• First Posted: Jul 21, 2020
• Last Update Posted: Sep 9, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders

Study Results

No Results Posted as of Sep 9, 2020