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NCT03776266 Clinical Trial

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

Percutaneous Coronary Intervention Clinical Trial

— TFPCI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03776266
Other study ID # SMC 2018-10-044
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 5, 2018
Est. completion date November 30, 2018

Study information
Verified date March 2019
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 48786
Est. completion date November 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Patients without any stent insertion

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• No intervention is required due to retrospective observational study
Red blood cell transfusion on or after percutaneous coronary intervention

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul Gang nam-Gu, Ilwon-Dong

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence density of transfusion 5-year incidence density of red blood cell transfusion 5 years
Secondary 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 5 years
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