The Long-term Clinical Outcomes and Patterns of Transfusion in Patients Undergoing Percutaneous Coronary Intervention (TFPCI)
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|ClinicalTrials.gov Identifier: NCT03776266|
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : December 14, 2018
|Condition or disease||Intervention/treatment|
|Erythrocyte Transfusion Percutaneous Coronary Intervention Revascularization||Procedure: Red blood cell transfusion|
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 Type :||Observational|
|Actual Enrollment :||48786 participants|
|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|
|Actual Study Start Date :||October 5, 2018|
|Actual Primary Completion Date :||November 30, 2018|
|Actual Study Completion Date :||November 30, 2018|
- Procedure: Red blood cell transfusion
Red blood cell transfusion on or after percutaneous coronary interventionOther Name: percutaneous coronary intervention
- Incidence density of transfusion [ Time Frame: 5 years ]5-year incidence density of red blood cell transfusion
- Incidence density of MACE [ Time Frame: 5 years ]5-year incidence densities of a major adverse clinical event (MACE) consisting of all-cause death, revascularization, critically ill cardiovascular status, and stroke
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776266
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Gang nam-Gu, Ilwon-Dong, Korea, Republic of, 135-710|
|Principal Investigator:||Jin-Ho Choi, MD, PhD||Samsung Medical Center|