Status:
COMPLETED
Therapeutic Plasma Exchange for COVID-19-associated Hyperviscosity
Lead Sponsor:
Emory University
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Many patients with Coronavirus Disease 2019 (COVID-19) have atypical blood clots. These blood clots can occur in either veins or arteries and be large, like in stroke or heart attack, or very tiny, ca...
Detailed Description
Critically ill COVID-19 patients have high rates of complications, including respiratory failure, renal impairment, and a coagulopathic state that may exacerbate these conditions and contribute to add...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Patients admitted to the ICU at Emory University Hospital, Emory University Hospital Midtown, or Emory Saint Joseph's Hospital
- Evidence of COVID-19 infection documented by a laboratory test either by one of the following:
- A diagnostic test (e.g., nasopharyngeal swab, tracheal aspirate, other)
- Positive serological test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies
- Medical records from outside institution
- Plasma viscosity \>2.3 and \<3.5 centipoise (cp) or Fibrinogen \>800 mg/dL
Exclusion
- Patients with plasma viscosity \> 3.5 cp
- Moribund patients that the ICU clinical team expects to die within 24 hours
- Patients with any condition that, in the opinion of the clinical team or investigator, could increase the subject's risk by participating in the study or confound the outcome of the study
- Patients participating in another clinical trial that prohibits the use of TPE
- Pregnant women
- Prisoners
Key Trial Info
Start Date :
July 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04441996
Start Date
July 17 2020
End Date
March 18 2021
Last Update
December 21 2022
Active Locations (3)
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1
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30308
2
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
3
Emory University Hospital
Atlanta, Georgia, United States, 30322