NCT03788148

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28,322

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 27, 2018

Completed
Last Updated

December 27, 2018

Status Verified

December 1, 2018

Enrollment Period

11 months

First QC Date

December 14, 2018

Last Update Submit

December 26, 2018

Conditions

Erythrocyte TransfusionPercutaneous Coronary InterventionRevascularization

Keywords

transfusion, PCI, DES, BMS

Outcome Measures

Primary Outcomes (2)

  • Incidence density of MACE (Major adverse clinical events)

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

    3 years

  • Incidence density of MACE (Major adverse clinical events)

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

    1 year

Interventions

Stent, red blood cell transfusionDEVICE

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All Korean patients undergoing BMS or DES implantation from January 1, 2005 to December 31, 2016 who received periprocedural red blood cell transfusion

You may qualify if:

  • 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

You may not qualify if:

  • Patients without any of stent implantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

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

Location

MeSH Terms

Conditions

Dysequilibrium syndrome

Interventions

StentsErythrocyte Transfusion

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and SuppliesBlood Component TransfusionBlood TransfusionBiological TherapyTherapeutics

Study Officials

  • Jin-Ho Choi, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor, Principal Investigator

Study Record Dates

First Submitted

December 14, 2018

First Posted

December 27, 2018

Study Start

January 3, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

December 27, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)