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临床试验/NCT05357885
NCT05357885已完成不适用

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

Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年11月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
assess antibody levels before and after CPB.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patients with indeterminant history of vaccination schedule.

结局指标

主要结局

assess antibody levels before and after CPB.

时间窗: preop and up to 5 days post op

assess antibody levels before and after CPB.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jordan Goldhammer, MD

Associate Professor

Thomas Jefferson University

研究点 (1)

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