NCT05800691

Brief Summary

Blalock Taussig (BT) is a palliative procedure that preserves blood circulation to the lungs and alleviates cyanosis in patients with congenital heart diseases and reduced pulmonary blood flow. BT shunt remains a routinely performed procedure in developing countries before definitive surgery. However, evidence on predictors factors of mortality after this procedure is still scarce in Indonesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

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

November 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

March 12, 2023

Last Update Submit

August 4, 2023

Conditions

Cyanotic Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • In-Hospital Mortality

    Death occured to patients during in hospital stay

    November 2020 - January 2021

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The population of this study is CHD pediatric patients with a previous history of BT shunt procedure

You may qualify if:

  • All CHD pediatric patients with a previous history of BT shunt procedure.

You may not qualify if:

  • Pediatric patients with incomplete medical records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Sumatera Utara

Medan, North Sumatera, 20155, Indonesia

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr. Putri Amelia, M.Ked (Ped), Sp.A(K)

Study Record Dates

First Submitted

March 12, 2023

First Posted

April 5, 2023

Study Start

November 1, 2020

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

August 8, 2023

Record last verified: 2023-08

Locations

ID(1)