Cardiac DiseaseNCT02653885
Haematologic Predictors and Clinical Outcome in Cardiac Surgery
An observational study of Cardiac Disease, run by Ankara University.
Trial summary
The outcome predictors for cardiac surgery has been popular for many researchers and clinicians. Determining risk factors before surgery reduce morbidity and mortality after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Red red cell distribution width
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cardiac patients needed cardiac surgery
Who may be able to join
- elective, on-pump cardiac surgery
Who cannot join
- emergent cases
- pediatric cases
- congenital surgery
- heart transplantation
About this study
The outcome predictors for cardiac surgery has been popular for many researchers and clinicians. Determining risk factors before surgery reduce morbidity and mortality after surgery. Some routine blood results have been used as predictors for cardiac surgery but none of the researches studied red cell distribution width, mean platelet volume, platelet/lymphocyte ratio and neutrophil/lymphocyte ratio. This study focused on these parameters and to see whether these parameters can be predictors for cardiac surgery.
- Conditions
- Cardiac Disease
- Being tested
- Red red cell distribution width
- Keywords
- cardiac surgery, open heart surgery, hemogram
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red red cell distribution widthOther
Also called Mean platelet volume, Platelet/lymphocyte ratio, Neutrophil/lymphocyte ratio
Results from hemogram
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of combined adverse effects
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startJan 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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 crossover
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CIGDEM YILDIRIM GUCLU, Ankara University
- Investigators
- CIGDEM YILDIRIM GUCLU, MD, Study chair, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653885
- Sponsor's protocol ID
- YIH
- Status last verified
- Jan 2016
- First submitted
- 11 Jan 2016
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haematologic Predictors and Clinical Outcome in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02653885
- Acronym / sponsor ID
- YIH
- Conditions
- Cardiac Disease
- Keywords
- cardiac surgery, open heart surgery, hemogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Jan 2016 (estimated)
- 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.
The outcome predictors for cardiac surgery has been popular for many researchers and clinicians. Determining risk factors before surgery reduce morbidity and mortality after surgery. Some routine blood results have been used as predictors for cardiac surgery but none of the researches studied red cell distribution width, mean platelet volume, platelet/lymphocyte ratio and neutrophil/lymphocyte ratio. This study focused on these parameters and to see whether these parameters can be predictors for cardiac surgery.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cardiac patients needed cardiac surgery
Key inclusion criteria (1 listed)
- elective, on-pump cardiac surgery
Key exclusion criteria (4 listed)
- emergent cases
- pediatric cases
- congenital surgery
- heart transplantation
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 |
|---|---|---|
| Red red cell distribution widthAlso: Mean platelet volume, Platelet/lymphocyte ratio, Neutrophil/lymphocyte ratioResults from hemogram | Other | – |
Primary outcome
incidence of combined adverse effects
Time frame: 48 hours
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 13 Jan 2016.
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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.
CIGDEM YILDIRIM GUCLU, MD study chair
Ankara University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by Ankara University.
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 13 Jan 2016. 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?
incidence of combined adverse effects (time frame: 48 hours). 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 13 Jan 2016.