NCT05094960

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2011

Completed
10.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
Last Updated

November 5, 2021

Status Verified

October 1, 2021

Enrollment Period

1.6 years

First QC Date

October 12, 2021

Last Update Submit

October 28, 2021

Conditions

Correlation of cFDNA During CPB to Laboratories SIRS Parameters and Clinical Outcomes

Keywords

cfDNA-Circulating cell-free DNACPB-cardiopulmonary bypassSIRS-systemic inflammatory response syndrome

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Neutrophil-NETosis

    2 hours after the surgery

Interventions

Blood samplesDIAGNOSTIC_TEST

5 blood samples for each patient during CABG (coronary artery bypass grafting) surgery pre/on/post cardiopulmonary bypass machine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Elective coronary artery bypass grafting surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood test

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
8 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2021

First Posted

October 26, 2021

Study Start

July 30, 2009

Primary Completion

March 22, 2011

Study Completion

July 30, 2021

Last Updated

November 5, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share