NCT06889272

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

February 18, 2025

Last Update Submit

March 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • postoperative acute renal failure

    From registration to the end of the second postoperative day

Study Arms (2)

patients with acute kidney injury

blood transfusion during surgery

Other: blood transfusion

patients without acute kidney injury

blood transfusion during surgery

Other: blood transfusion

Interventions

Red blood cell suspension replacement during surgery

patients with acute kidney injurypatients without acute kidney injury

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • pediatric patients undergoing cardiovascular surgery

You may not qualify if:

  • Being over 18 years old Weighting over 30 kg Preoperative acute kidney injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Anesthesiology and Reanimation

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Defects, CongenitalAcute Kidney InjuryTransfusion Reaction

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHematologic DiseasesHemic and Lymphatic DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Murat Izgi

    Assistant professor

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 18, 2025

First Posted

March 21, 2025

Study Start

January 31, 2024

Primary Completion

April 1, 2024

Study Completion

June 30, 2024

Last Updated

March 21, 2025

Record last verified: 2025-03

Locations