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

NCT ID: NCT03776266

Last Updated: 2019-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48786 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-05

Study Completion Date

2018-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Erythrocyte Transfusion Percutaneous Coronary Intervention Revascularization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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No intervention is required due to retrospective observational study

Red blood cell transfusion on or after percutaneous coronary intervention

Intervention Type PROCEDURE

Other Intervention Names

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Observation on Red blood cell transfusion on or after percutaneous coronary intervention

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients without any stent insertion
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jin-Ho Choi

MD, PhD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Ho Choi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

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

Site Status

Countries

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South Korea

Other Identifiers

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SMC 2018-10-044

Identifier Type: -

Identifier Source: org_study_id

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