Coagulation Changes Associated With COVID-19 Infection
Exploratory Assessment of the Coagulation Changes Associated With Severe Inflammation in COVID-19 Patients
1 other identifier
observational
15
1 country
1
Brief Summary
This study will study the potential utility of the Quantra QPlus System in patients inflicted with COVID-19 disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedStudy Start
First participant enrolled
August 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2022
CompletedMay 13, 2022
May 1, 2022
9 months
June 30, 2020
May 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Quantra Clot Time results
Coagulation function assessed by the Quantra
Within 24 hours of admission to the hospital
Quantra Clot Time results
Coagulation function assessed by the Quantra
48 to 72 hours after transfer to ICU
Quantra Clot Time results
Coagulation function assessed by the Quantra
1 to 24 hours prior to discharge from hospital
Quantra Clot Stiffness results
Coagulation function assessed by the Quantra
Upon arrival at hospital
Quantra Clot Stiffness results
Coagulation function assessed by the Quantra
48 to 72 hours after transfer to ICU
Quantra Clot Stiffness results
Coagulation function assessed by the Quantra
1 to 24 hours prior to discharge from hospital
Study Arms (2)
Subjects admitted to floor
COVID-19 patients admitted to the floor as initial place of hospitalization
Subjects admitted or transferred to ICU
COVID-19 patients admitted to the ICU as initial place of hospitalization or transferred to ICU from floor
Interventions
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Eligibility Criteria
Potential subjects will be adult (\>=18 years) patients with a diagnosis of COVID-19 disease admitted to the hospital for treatment of their disease. Subjects will be enrolled at a ratio of 1 admitted to floor for every 2 admitted to ICU as initial place of hospitalization.
You may qualify if:
- Subject is ≥ 18 years of age
- Subject has a diagnosis of COVID-19 and has been admitted to the hospital
- Subject has one or more risk factors for a poor outcome with COVID-10 disease: advanced age (\>=60 years), morbid obesity, diabetes, COPD, CAD
- Subject, or subject's legally authorized representative is willing and agrees to provide informed consent.
You may not qualify if:
- Subject is younger than 18 years of age
- Subject is pregnant
- Subject is incarcerated.
- Subject, or subject's legally authorized representative is unable or unwilling to provide informed consent.
- Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HemoSonics LLClead
Study Sites (1)
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, 79905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2020
First Posted
July 7, 2020
Study Start
August 14, 2020
Primary Completion
April 28, 2021
Study Completion
January 26, 2022
Last Updated
May 13, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share