NCT03776266

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48,786

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 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

October 5, 2018

Completed
2 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
13 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

2 months

First QC Date

December 13, 2018

Last Update Submit

March 26, 2019

Conditions

Erythrocyte TransfusionPercutaneous Coronary InterventionRevascularization

Keywords

TransfusionPCIPercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

  • Incidence density of transfusion

    5-year incidence density of red blood cell transfusion

    5 years

Secondary Outcomes (1)

  • Incidence density of MACE

    5 years

Interventions

No intervention is required due to retrospective observational studyPROCEDURE

Red blood cell transfusion on or after percutaneous coronary intervention

Also known as: Observation on Red blood cell transfusion on or after percutaneous coronary intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Patients without any stent insertion

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

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

Study Record Dates

First Submitted

December 13, 2018

First Posted

December 14, 2018

Study Start

October 5, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

March 28, 2019

Record last verified: 2019-03

Locations

KR(1)