NCT02646254

Brief Summary

Myocardial protection and clinical outcome in patients Undergoing tetralogy of fallot repair: a randomized study of Two cardioplegic techniques.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2014

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

June 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
Last Updated

January 5, 2016

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

December 24, 2015

Last Update Submit

December 31, 2015

Conditions

Myocardial Protection in TOF Repair

Keywords

tetralogy of fallot, cardioplegia

Outcome Measures

Primary Outcomes (3)

  • inotropic score

    First 24 hours

  • Creatine kinase MB level baseline preoperative and postoperative 0, 6, 24, and 72 hours

    72hrs

  • resumption of spontaneous rhythm after aortic cross clamp off

    10 minutes

Secondary Outcomes (4)

  • duration of mechanical ventilation in hours

    48 hours

  • ICU stay

    7 days

  • hospital mortality

    30 days

  • echocardiographic assessment

    6 months

Study Arms (2)

blood cardioplegia

ACTIVE COMPARATOR

these patients received blood cardioplegia

Other: blood cardioplegia

del nido cardioplegia

ACTIVE COMPARATOR

these patients received del nido cardioplegia

Other: del nido cardioplegia

Interventions

blood cardioplegiaOTHER
blood cardioplegia
del nido cardioplegiaOTHER
del nido cardioplegia

Eligibility Criteria

Age1 Year - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Tetralogy of fallot

You may not qualify if:

  • TOF with absent pulmonary valve , TOF with pulmonary atresia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tetralogy of Fallot

Interventions

Del Nido cardioplegia solution

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
UNKNOWN
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Fellow, Cardiac anesthesia.

Study Record Dates

First Submitted

December 24, 2015

First Posted

January 5, 2016

Study Start

June 1, 2014

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

January 5, 2016

Record last verified: 2015-12