NCT04367701

Brief Summary

Authors compared incidence of Hemolysis on Cardiopulmonary Bypass surgery for repair of congenital heart disease in Pediatric Patients between patients with thalassemia major and control group

Trial Health

100
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2012

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

7.6 years

First QC Date

April 27, 2020

Last Update Submit

April 27, 2020

Conditions

Hemolysis

Outcome Measures

Primary Outcomes (1)

  • Hemolysis

    Authors measure hemolysis by free plasma hemoglobin concentration

    3 hours

Study Arms (2)

Thalassemia group

16 pediatric patients with thalassemia major undergoing surgery for repair of congenital heart disease. Authors measure hemolysis by free plasma hemoglobin concentration.

Diagnostic Test: Hemolysis

Control group

25 pediatric patients with demographic data related to those in thalassemia group, undergoing surgery for repair of congenital heart disease. Authors measure hemolysis by free plasma hemoglobin concentration

Diagnostic Test: Hemolysis

Interventions

HemolysisDIAGNOSTIC_TEST

Authors measured free plasma hemoglobin concentration in gram

Control groupThalassemia group

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients with thalassemia major undergoing surgical repair for congenital heart disease

You may qualify if:

  • Pediatric Patients with thalassemia major.
  • Pediatric Patients with congenital heart disease undergoing surgical repair.

You may not qualify if:

  • known hepatic or renal disease
  • uncontrolled active hemolytic reaction
  • emergency surgery
  • redo surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemolysis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Galal Mo El kadi, Doctor

    Professor

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 27, 2020

First Posted

April 29, 2020

Study Start

January 15, 2012

Primary Completion

August 15, 2019

Study Completion

August 30, 2019

Last Updated

April 29, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share