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

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

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

Study Overview

• Status: Completed
• Conditions: Laboratory Assessment SARS-CoV-2 Antibody Levels Before and After Surgery for Patients Requiring Cardiopulmonary Bypass
• Intervention / Treatment: Diagnostic test: SARS-CoV-2 Antibody test

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult 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

Description

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.

Exclusion Criteria:

• Age < 18.
• Patients with indeterminant history of vaccination schedule.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess antibody levels before and after CPB.	assess antibody levels before and after CPB.	preop and up to 5 days post op

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 17, 2021
• Primary Completion (ACTUAL): March 17, 2022
• Study Completion (ACTUAL): March 17, 2022

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (ACTUAL): May 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 21D.1055

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No