Quantitative COVID-19 SARS-CoV-2 Antibody Pre and Post Cardiopulmonary Bypass

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-17

Study Completion Date

2022-03-17

Brief Summary

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This study is designed to compare the levels of SARS-CoV-2 antibody prior to cardiopulmonary bypass and after cardiopulmonary bypass (CPB).

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Detailed Description

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This study is designed to compare the levels of SARS-CoV-2 antibody prior to cardiopulmonary bypass and after cardiopulmonary bypass (CPB).

During CPB the patients' blood volume is removed from the body and sent through the CPB machine. CPB consists of a pump (to keep blood moving) and oxygenator (to oxygenate blood). The oxygenator or CPB circuitry may effect antibody levels. In addition, patients on CPB experience hemodilution from blood transfusion and priming volume from the CPB circuit. Hemodilution may effect antibody levels.

Prior to CPB, during standard of care lab drawn from standard of care arterial catheter, 0.5ml of plasma will be sent to the TJUH microbiology lab for Roche Elecsys Anti-SARS-CoV-2 immunoassay for pre-CPB quantitative antibody testing.

On morning of postoperative day 1, during standard of care lab draw from standard of care arterial catheter, 0.5ml of plasma will be sent to the TJUH microbiology lab for Roche Elecsys Anti-SARS-CoV-2 immunoassay for post-CPB quantitative antibody testing.

On morning of postoperative day 5, during standard of care lab draw, 0.5ml of plasma will be sent to the TJUH microbiology lab for Roche Elecsys Anti-SARS-CoV-2 immunoassay for post-CPB quantitative antibody testing. If patient is discharged from the hospital prior to postoperative day #5, this immunoassay will be omitted.

Conditions

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Laboratory Assessment SARS-CoV-2 Antibody Levels Before and After Surgery for Patients Requiring Cardiopulmonary Bypass

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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SARS-CoV-2 Antibody test

SARS-CoV-2 antibody test at Jefferson is Roche Elecsys Anti-SARS-CoV-2 immunoassays performed under FDA's Emergency Use Authorization.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* All patients presenting for elective cardiac surgery with the use of cardiopulmonary bypass that have received 2 or 3 doses of FDA approved or Emergency Use Authorization Covid vaccine.