Congenital Cardiac DefectNCT06889272
Investigation of the Relationship Between Blood Transfusion Volume and Development of Renal Failure in Pediatric Patients Undergoing Cardiovascular Surgery
An observational study of Congenital Cardiac Defect and Acute Renal Injury, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Blood transfusion strategies in cardiac surgery are a research topic that has been studied more for adults. There is not enough data on this subject for children in studies. Investigators aim to examine the renal damage risk level of blood transfusion volume, which is one of the modifiable risk factors that can cause… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Cardiac Defect, Acute Renal Injury, Blood Transfusion Complication
- What is being tested?
- blood transfusion
- How many people
- 205 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2024to 30 Jun 2024
- 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 Up to 18 years
- All sexes
- Child, Adult
Study population: Pediatric patients who applied to Hacettepe University Faculty of Medicine (HÜTF) Hospital and underwent cardiac surgery by the Department of Cardiovascular Surgery between January 1, 2013 and December 31, 2023 will be included in the study.
Who may be able to join
- pediatric patients undergoing cardiovascular surgery
Who cannot join
- Being over 18 years old Weighting over 30 kg Preoperative acute kidney injury
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Anesthesiology and Reanimation
Ankara
About this study
Blood transfusion strategies in cardiac surgery are a research topic that has been studied more for adults. There is not enough data on this subject for children in studies. Investigators aim to examine the renal damage risk level of blood transfusion volume, which is one of the modifiable risk factors that can cause acute kidney injury in pediatric cases undergoing cardiac surgery.
The main question it aims to answer is:
What is the effect of blood transfusion volume on the risk of renal damage in pediatric cardiovascular surgery? The names of the patients who were operated on by the Department of Cardiovascular Surgery will be accessed from the system records and their files will be reviewed. The patients' demographic information, anesthesia management and postoperative renal function tests will be scanned.
- Being tested
- blood transfusion
- Medical subject headings
- Heart Defects, Congenital, Acute Kidney Injury, Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood transfusionOther
Red blood cell suspension replacement during surgery
| Study group | Role | What they receive |
|---|---|---|
| patients with acute kidney injury | blood transfusion during surgery Receives: Other: blood transfusion | |
| patients without acute kidney injury | blood transfusion during surgery Receives: Other: blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative acute renal failure
Measured: From registration to the end of the second postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start31 Jan 2024
- Primary completion1 Apr 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Cardiac DefectStudies of the same condition, open and under way.
- More trials run by Hacettepe 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-control
- Time perspective
- Retrospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat İzgi, Hacettepe University
- Investigators
- Murat Izgi, Study director, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889272
- Sponsor's protocol ID
- Yusuf CELIK
- Other IDs
- Murat IZGI
- Status last verified
- Mar 2025
- First submitted
- 18 Feb 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Blood Transfusion Volume and Development of Renal Failure in Pediatric Patients Undergoing Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT06889272
- Acronym / sponsor ID
- Yusuf CELIK
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 21 Mar 2025 (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.
Blood transfusion strategies in cardiac surgery are a research topic that has been studied more for adults. There is not enough data on this subject for children in studies. Investigators aim to examine the renal damage risk level of blood transfusion volume, which is one of the modifiable risk factors that can cause acute kidney injury in pediatric cases undergoing cardiac surgery.
The main question it aims to answer is:
What is the effect of blood transfusion volume on the risk of renal damage in pediatric cardiovascular surgery? The names of the patients who were operated on by the Department of Cardiovascular Surgery will be accessed from the system records and their files will be reviewed. The patients' demographic information, anesthesia management and postoperative renal function tests will be scanned.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with acute kidney injury | – | Other: blood transfusionblood transfusion during surgery |
| patients without acute kidney injury | – | Other: blood transfusionblood transfusion during surgery |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Pediatric patients who applied to Hacettepe University Faculty of Medicine (HÜTF) Hospital and underwent cardiac surgery by the Department of Cardiovascular Surgery between January 1, 2013 and December 31, 2023 will be included in the study.
Key inclusion criteria (1 listed)
- pediatric patients undergoing cardiovascular surgery
Key exclusion criteria (1 listed)
- Being over 18 years old Weighting over 30 kg Preoperative acute kidney injury
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 |
|---|---|---|
| blood transfusionRed blood cell suspension replacement during surgery | Other | patients with acute kidney injury, patients without acute kidney injury |
Primary outcome
postoperative acute renal failure
Time frame: From registration to the end of the second postoperative day
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 21 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Murat Izgi study director
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Cardiac Defect and Acute Renal Injury, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
postoperative acute renal failure (time frame: From registration to the end of the second postoperative day). 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 21 Mar 2025.