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OpenTrials
Completed

NCT Number: NCT05094960

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective coronary artery bypass grafting surgery

Exclusion criteria

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

Treatment and study plan

Blood samples

Diagnostic Test

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

Primary outcomes

  1. prolong LOS-length of stay

    Time frame: > 18 hours after the surgery

    intensive care unit length of stay

  2. Mortality

    Time frame: short term - 30day; long term > 1year

    Mortality

Secondary outcomes

  1. Neutrophil-NETosis

    Time frame: 2 hours after the surgery

    Neutrophil extracellular traps (NETs) released from activated neutrophils that undergo NETosis.

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2021
First posted
Oct 26, 2021
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.