Laboratory Assessment SARS-CoV-2 Antibody Levels Before and After Surgery for Patients Requiring Cardiopulmonary BypassNCT05357885
Quantitative COVID-19 SARS-CoV-2 Antibody Pre and Post Cardiopulmonary Bypass
An observational study of Laboratory Assessment SARS-CoV-2 Antibody Levels Before and After Surgery for Patients Requiring Cardiopulmonary Bypass, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This study is designed to compare the levels of SARS-CoV-2 antibody prior to cardiopulmonary bypass and after cardiopulmonary bypass (CPB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laboratory Assessment SARS-CoV-2 Antibody Levels Before and After Surgery for Patients Requiring Cardiopulmonary Bypass
- What is being tested?
- SARS-CoV-2 Antibody test
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2021to 17 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Age < 18.
- Patients with indeterminant history of vaccination schedule.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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).
Read the 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.
- Being tested
- SARS-CoV-2 Antibody test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 Antibody testDiagnostic test
SARS-CoV-2 antibody test at Jefferson is Roche Elecsys Anti-SARS-CoV-2 immunoassays performed under FDA's Emergency Use Authorization.
What is being measured
The primary outcome is the main question the study is designed to answer.
assess antibody levels before and after CPB.
assess antibody levels before and after CPB.
Measured: preop and up to 5 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start17 Nov 2021
- Primary completion17 Mar 2022
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laboratory Assessment SARS-CoV-2 Antibody Levels Before and After Surgery for Patients Requiring Cardiopulmonary BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordan Goldhammer, MD, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357885
- Sponsor's protocol ID
- 21D.1055
- Status last verified
- Apr 2022
- First submitted
- 17 Nov 2021
- Last updated
- 3 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative SARS-CoV-2 Antibody Pre and Post Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT05357885
- Acronym / sponsor ID
- 21D.1055
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to compare the levels of SARS-CoV-2 antibody prior to cardiopulmonary bypass and after cardiopulmonary bypass (CPB).
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Age < 18.
- Patients with indeterminant history of vaccination schedule.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 Antibody testSARS-CoV-2 antibody test at Jefferson is Roche Elecsys Anti-SARS-CoV-2 immunoassays performed under FDA's Emergency Use Authorization. | Diagnostic test | – |
Primary outcome
assess antibody levels before and after CPB.
Time frame: preop and up to 5 days post op
assess antibody levels before and after CPB.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laboratory Assessment SARS-CoV-2 Antibody Levels Before and After Surgery for Patients Requiring Cardiopulmonary Bypass, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess antibody levels before and after CPB. (time frame: preop and up to 5 days post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.