Skip to main content
OpenTrials
Completed

NCT Number: NCT03788148

Bare Metal Stents and Drug Eluting Stents in Patients Who Underwent Blood Transfusion

Retrospective cohort study of Korean National Healthcare Insurance Database. To investigate clinical outcomes of bare metal stents versus drug eluting stents in patients who underwent periprocedural red blood cell transfusion.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Erythrocyte Transfusion Dysequilibrium syndrome 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 Korean nationwide, multi-center, retrospective observational cohort study.

The receipt of red blood cell transfusion is at high risk of cardiac events or death. But little is know regarding the comparative outcomes of BMS and DES implantation in patients who underwent periprocedural red blood cell transfusion.

Longitudinal data is collected from administrative claims in the national health insurance services of Korea. All Korean data(N=500,591) undergoing PCI from 2006 to 2015 is extracted. BMS or DES Patients(N=28,322) who received periprocedural red blood cell transfusion is investigate. Clinical outcomes until December 31, 2017 is investigate.

Primary endpoint is a time to the first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, or stroke.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with percutaneous coronary intervention from 2006 to 2015
  • Patients with the implantation of BMS or DES
  • Patients with the receipt of periprocedural red blood cell transfusion

Exclusion criteria

  • Patients without any of stent implantation

Treatment and study plan

Stent, red blood cell transfusion

Device

BMS (Bare Metal Stent) and DES (drug-eluting stent) transplants with periprocedural red blood cell transfusion

Primary outcomes

  1. Incidence density of MACE (Major adverse clinical events)

    Time frame: 3 years

    The first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, and stroke.

  2. Incidence density of MACE (Major adverse clinical events)

    Time frame: 1 year

    The first major adverse clinical event(MACE) defined as a composite 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

Bare-metal Stents(BMS) Versus Drug-eluting Stents(DES) in Patients Who Underwent Periprocedural Blood Transfusion : A Nationwide Longitudinal Cohort Study

Acronym: TFPCI2

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 27, 2018
Registry last updated
Dec 27, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.