Correlation of cFDNA During CPB to Laboratories SIRS Parameters and Clinical OutcomesNCT05094960
Measurement of Circulating Cell-free DNA (cfDNA) for Diagnosis and Prognosis of Various Diseases and Evaluation of Tissue Damage
An observational study of Correlation of cFDNA During CPB to Laboratories SIRS Parameters and Clinical Outcomes, run by Soroka University Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Correlation of cFDNA During CPB to Laboratories SIRS Parameters and Clinical Outcomes
- What is being tested?
- Blood samples
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2009to 30 Jul 2021
- How long will I take part?
- 8 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult (>18yo), undergoing non-emergent first-time CABG.
Who may be able to join
- Elective coronary artery bypass grafting surgery
Who cannot join
- Age < 18
- Non elective surgery
- other than CABG surgery
- Redo CABG
About this study
Official 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
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.
Read the 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.
- Being tested
- Blood samples
- Keywords
- cfDNA-Circulating cell-free DNA, CPB-cardiopulmonary bypass, SIRS-systemic inflammatory response syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesDiagnostic test
5 blood samples for each patient during CABG (coronary artery bypass grafting) surgery pre/on/post cardiopulmonary bypass machine
What is being measured
The primary outcome is the main question the study is designed to answer.
prolong LOS-length of stay
intensive care unit length of stay
Measured: > 18 hours after the surgery
Mortality
Mortality
Measured: short term - 30day; long term > 1year
Secondary outcomes (1)
Neutrophil-NETosis
Neutrophil extracellular traps (NETs) released from activated neutrophils that undergo NETosis.
Measured: 2 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start30 Jul 2009
- Primary completion22 Mar 2011
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Correlation of cFDNA During CPB to Laboratories SIRS Parameters and Clinical OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094960
- Sponsor's protocol ID
- SOR4636CTIL
- Status last verified
- Oct 2021
- First submitted
- 12 Oct 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05094960
- Acronym / sponsor ID
- SOR4636CTIL
- Keywords
- cfDNA-Circulating cell-free DNA, CPB-cardiopulmonary bypass, SIRS-systemic inflammatory response syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- 30 Jul 2009 (actual)
- Primary completion
- 22 Mar 2011 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 8 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult (>18yo), undergoing non-emergent first-time CABG.
Key inclusion criteria (1 listed)
- Elective coronary artery bypass grafting surgery
Key exclusion criteria (4 listed)
- Age < 18
- Non elective surgery
- other than CABG surgery
- Redo CABG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples5 blood samples for each patient during CABG (coronary artery bypass grafting) surgery pre/on/post cardiopulmonary bypass machine | Diagnostic test | – |
Primary outcome
prolong LOS-length of stay
Time frame: > 18 hours after the surgery
intensive care unit length of stay
Mortality
Time frame: short term - 30day; long term > 1year
Mortality
1 secondary outcome
Neutrophil-NETosis
Time frame: 2 hours after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Correlation of cFDNA During CPB to Laboratories SIRS Parameters and Clinical Outcomes, run by Soroka University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prolong LOS-length of stay (time frame: > 18 hours after the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.