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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
Sponsor:
Information provided by (Responsible Party):
Jin-Ho Choi, Samsung Medical Center

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

Condition or disease Intervention/treatment
Erythrocyte Transfusion Percutaneous Coronary Intervention Revascularization Procedure: Red blood cell transfusion

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.


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Study Type : Observational
Actual Enrollment : 48786 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Red blood cell transfusion
    Red blood cell transfusion on or after percutaneous coronary intervention
    Other Name: percutaneous coronary intervention


Primary Outcome Measures :
  1. Incidence density of transfusion [ Time Frame: 5 years ]
    5-year incidence density of red blood cell transfusion


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing PCI using stent in 2011 from all medical providers in Korea is selected using National Healthcare Insurance System
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients without any stent insertion

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Gang nam-Gu, Ilwon-Dong, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Jin-Ho Choi, MD, PhD Samsung Medical Center

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Responsible Party: Jin-Ho Choi, MD, PhD, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03776266     History of Changes
Other Study ID Numbers: SMC 2018-10-044
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jin-Ho Choi, Samsung Medical Center:
Transfusion
PCI
Percutaneous Coronary Intervention