Measurement of Circulating Cell-free DNA (cfDNA) for Diag... | NCT05094960

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 30, 2009Actual

Primary Completion Date

Mar 22, 2011Actual

Completion Date

Jul 30, 2021Actual

First Submitted Date

Oct 12, 2021

First Submission Date that Met QC Criteria

Oct 24, 2021

First Posted Date

Oct 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2021

Last Update Posted Date

Nov 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

8 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

71Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood samples	Diagnostic Test	5 blood samples for each patient during CABG (coronary artery bypass grafting) surgery pre/on/post cardiopulmonary bypass machine

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective coronary artery bypass grafting surgery

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D011677	Punctures
D013514	Surgical Procedures, Operative
D008919	Investigative Techniques