Measurement of Circulating Cell-free DNA (cfDNA) for Diagnosis and Prognosis of Various Diseases and Evaluation of Tissue Damage

Development of a Fast and Sensitive Method for Measurement of Circulating Cell-free DNA (cfDNA) for Diagnosis and Prognosis of Various Diseases and Evaluation of Tissue Damage Following Trauma

To characterize the changes in circulating cell-free DNA (cfDNA) levels during cardiopulmonary bypass (CPB) and to access their association with outcomes compared to standard scores.

Study Overview

• Status: Completed
• Conditions: Correlation of cFDNA During CPB to Laboratories SIRS Parameters and Clinical Outcomes
• Intervention / Treatment: Diagnostic test: Blood samples

Detailed Description

In a prospective study, the investigators enrolled seventy-one consecutive patients undergoing non-emergent coronary artery bypass grafting. Blood was drawn at baseline, after 20 and 40 minutes on CPB, after cross-clamp removal, and 30 minutes after chest closure. cfDNA was measured in sera by fluorescent method.

The investigators hypothesize that cfDNA measured by will reflect the magnitude of inflammation induced by CPB. Thus, these measurements could serve for the real-time prognosis of patients undergoing cardiac surgery. The investigators correlate cFDNA to laboratories and clinical outcomes.

• Study Type: Observational
• Enrollment (Actual): 71

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: Probability Sample

Study Population

adult (>18yo), undergoing non-emergent first-time CABG.

Description

Inclusion Criteria:

• Elective coronary artery bypass grafting surgery

Exclusion Criteria:

• Age < 18
• Non elective surgery
• other than CABG surgery
• Redo CABG

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prolong LOS-length of stay	intensive care unit length of stay	> 18 hours after the surgery
Mortality	Mortality	short term - 30day; long term > 1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutrophil-NETosis	Neutrophil extracellular traps (NETs) released from activated neutrophils that undergo NETosis.	2 hours after the surgery

Collaborators and Investigators

• Sponsor: Soroka University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2009
• Primary Completion (Actual): March 22, 2011
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 24, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: cfDNA-Circulating cell-free DNA; CPB-cardiopulmonary bypass; SIRS-systemic inflammatory response syndrome
• Other Study ID Numbers: SOR4636CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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