Erythrocyte TransfusionTFPCINCT03776266
The Long-term Clinical Outcomes and Patterns of Transfusion in PCI Patients: Retrospective Cohort Study
An observational study of Erythrocyte Transfusion and Percutaneous Coronary Intervention, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
A nationwide retrospective cohort study. To investigate the long-term patterns of transfusion and clinical outcomes of patients undergoing PCI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Erythrocyte Transfusion, Percutaneous Coronary Intervention, Revascularization
- Type of treatment
- Surgery or procedure
- How many people
- 48,786 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Oct 2018to 30 Nov 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients undergoing PCI using stent in 2011 from all medical providers in Korea is selected using National Healthcare Insurance System
Who may be able to join
- All Korean patients undergoing PCI using stent from January 1, 2011 to December 31, 2011
Who cannot join
- Patients without any stent insertion
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center
Seoul, Gang nam-Gu, Ilwon-Dong, 135-710
About this study
Official title: The Five-year Pattern of Red Blood Cell Transfusion and Clinical Outcome in Patients Undergoing Percutaneous Coronary Intervention: A Korean Nationwide Longitudinal Cohort Study
A nationwide retrospective cohort study. To investigate the long-term patterns of transfusion and clinical outcomes of patients undergoing PCI.
Read the detailed description
A nationwide retrospective cohort study. Transfusion after PCI may increase a risk, but the long term effects after red blood cell transfusion is known. Longitudinal data is collected from administrative claims in the National Healthcare Insurance Service of Korea. All Korean patient date undergoing PCI inserting stent from January 1, 2011 to December 31, 2011 is extracted. Clinical outcomes until December 31, 2016 is investigated.
Primary outcome is the incidence density of red blood cell transfusion. Secondary outcomes are the association of transfusion with major adverse clinical event (MACE) consisting all-cause death, revascularization, critically ill cardiovascular status, or stroke.
Incidence density and time-dependent Cox proportional hazard regression is statistically analyzed.
- Being tested
- No intervention is required due to retrospective observational study
- Keywords
- Transfusion, PCI, Percutaneous Coronary Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is required due to retrospective observational studyProcedure or surgery
Also called Observation on Red blood cell transfusion on or after percutaneous coronary intervention
Red blood cell transfusion on or after percutaneous coronary intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence density of transfusion
5-year incidence density of red blood cell transfusion
Measured: 5 years
Secondary outcomes (1)
Incidence density of MACE
5-year incidence densities of a major adverse clinical event (MACE) consisting of all-cause death, revascularization, critically ill cardiovascular status, and stroke
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start5 Oct 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythrocyte TransfusionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 48,786 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Ho Choi, Samsung Medical Center
- Investigators
- Jin-Ho Choi, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776266
- Sponsor's protocol ID
- SMC 2018-10-044
- Acronym
- TFPCI
- Status last verified
- Mar 2019
- First submitted
- 13 Dec 2018
- Last updated
- 28 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Five-year Pattern of Red Blood Cell Transfusion and Clinical Outcome in Patients Undergoing Percutaneous Coronary Intervention: A Korean Nationwide Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT03776266
- Acronym / sponsor ID
- TFPCI / SMC 2018-10-044
- Keywords
- Transfusion, PCI, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48,786 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 14 Dec 2018 (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.
A nationwide retrospective cohort study. To investigate the long-term patterns of transfusion and clinical outcomes of patients undergoing PCI.
Detailed description
A nationwide retrospective cohort study. Transfusion after PCI may increase a risk, but the long term effects after red blood cell transfusion is known. Longitudinal data is collected from administrative claims in the National Healthcare Insurance Service of Korea. All Korean patient date undergoing PCI inserting stent from January 1, 2011 to December 31, 2011 is extracted. Clinical outcomes until December 31, 2016 is investigated.
Primary outcome is the incidence density of red blood cell transfusion. Secondary outcomes are the association of transfusion with major adverse clinical event (MACE) consisting all-cause death, revascularization, critically ill cardiovascular status, or stroke.
Incidence density and time-dependent Cox proportional hazard regression is statistically analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing PCI using stent in 2011 from all medical providers in Korea is selected using National Healthcare Insurance System
Key inclusion criteria (1 listed)
- All Korean patients undergoing PCI using stent from January 1, 2011 to December 31, 2011
Key exclusion criteria (1 listed)
- Patients without any stent insertion
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 |
|---|---|---|
| No intervention is required due to retrospective observational studyAlso: Observation on Red blood cell transfusion on or after percutaneous coronary interventionRed blood cell transfusion on or after percutaneous coronary intervention | Procedure or surgery | – |
Primary outcome
Incidence density of transfusion
Time frame: 5 years
5-year incidence density of red blood cell transfusion
1 secondary outcome
Incidence density of MACE
Time frame: 5 years
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 28 Mar 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Erythrocyte Transfusion
RecruitingObservational study
Transfusion-Related Changes in Oxidative Stress Biomarkers in Neonates
Oxidative Stress in Neonates, Near Infrared Spectroscopy
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.
Jin-Ho Choi, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erythrocyte Transfusion and Percutaneous Coronary Intervention, run by Samsung Medical Center at 1 site in South Korea.
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 1 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 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 density of transfusion (time frame: 5 years). 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 28 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.