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Completed

NCT Number: NCT03776266

The Long-term Clinical Outcomes and Patterns of Transfusion in PCI Patients: Retrospective Cohort Study

A nationwide retrospective cohort study. To investigate the long-term patterns of transfusion and clinical outcomes of patients undergoing PCI.

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Key information

Conditions

Erythrocyte Transfusion Percutaneous Coronary Intervention Revascularization

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, Gang nam-Gu, Ilwon-Dong, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All Korean patients undergoing PCI using stent from January 1, 2011 to December 31, 2011

Exclusion criteria

  • Patients without any stent insertion

Treatment and study plan

No intervention is required due to retrospective observational study

Procedure

Red blood cell transfusion on or after percutaneous coronary intervention

Other names: Observation on Red blood cell transfusion on or after percutaneous coronary intervention

Primary outcomes

  1. Incidence density of transfusion

    Time frame: 5 years

    5-year incidence density of red blood cell transfusion

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Acronym: TFPCI

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 14, 2018
Registry last updated
Mar 28, 2019

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.

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