HemolysisNCT04367701
Congenital Heart Surgery in Pediatric Patients With Beta-Thalassemia Major
An observational study of Hemolysis, run by Ain Shams University.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Hemolysis
- What is being tested?
- Hemolysis
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2012to 30 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- Child
Study population: Patients with thalassemia major undergoing surgical repair for congenital heart disease
Who may be able to join
- Pediatric Patients with thalassemia major.
- Pediatric Patients with congenital heart disease undergoing surgical repair.
Who cannot join
- known hepatic or renal disease
- uncontrolled active hemolytic reaction
- emergency surgery
- redo surgery
About this study
Official title: Congenital Heart Surgery in Pediatric Patients With Beta-Thalassemia Major : Analysis of Hemolysis During Cardiopulmonary Bypass
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
- Conditions
- Hemolysis
- Being tested
- Hemolysis
- Medical subject headings
- Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemolysisDiagnostic test
Authors measured free plasma hemoglobin concentration in gram
| Study group | Role | What they receive |
|---|---|---|
| Thalassemia group | 16 pediatric patients with thalassemia major undergoing surgery for repair of congenital heart disease.
Authors measure hemolysis by free plasma hemoglobin concentration. Receives: 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 Receives: Diagnostic Test: Hemolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemolysis
Authors measure hemolysis by free plasma hemoglobin concentration
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start15 Jan 2012
- Primary completion15 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemolysisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, simon Halim Armanious, Ain Shams University
- Investigators
- Galal Mo El kadi, Doctor, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367701
- Sponsor's protocol ID
- Thalassemia CHD
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congenital Heart Surgery in Pediatric Patients With Beta-Thalassemia Major : Analysis of Hemolysis During Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT04367701
- Acronym / sponsor ID
- Thalassemia CHD
- Conditions
- Hemolysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jan 2012 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thalassemia group | – | Diagnostic Test: Hemolysis16 pediatric patients with thalassemia major undergoing surgery for repair of congenital heart disease. Authors measure hemolysis by free plasma hemoglobin concentration. |
| Control group | – | Diagnostic Test: Hemolysis25 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 |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Patients with thalassemia major undergoing surgical repair for congenital heart disease
Key inclusion criteria (2 listed)
- Pediatric Patients with thalassemia major.
- Pediatric Patients with congenital heart disease undergoing surgical repair.
Key exclusion criteria (4 listed)
- known hepatic or renal disease
- uncontrolled active hemolytic reaction
- emergency surgery
- redo surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemolysisAuthors measured free plasma hemoglobin concentration in gram | Diagnostic test | Control group, Thalassemia group |
Primary outcome
Hemolysis
Time frame: 3 hours
Authors measure hemolysis by free plasma hemoglobin concentration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galal Mo El kadi, Doctor study chair
Professor
Questions about this trial
What is this clinical trial studying?
An observational study of Hemolysis, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemolysis (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.