Tokyo, April 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061385) titled 'A Study on Minimizing Blood Transfusion Volume by Suppressing Blood Dilution During Cardiopulmonary Bypass Initiation in Pediatric Cardiac Surgery' on April 27.

Study Type: Observational

Primary Sponsor: Institute - International University of Health and Welfare

Condition: Condition - Ventricular septal defect, Atrial septal defect Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - A cardiopulmonary bypass (CPB) is a device that circulates oxygenated blood throughout the body while the heart is stopped for surgery, making it essential for performing cardiac surgery safely. CPB is initially filled with priming fluid. When CPB starts, this fluid dilutes the patient's blood. As the red blood cell concentration decreases, there is a risk of insufficient oxygen delivery to tissues, necessitating transfusion. Red blood cell transfusion has been associated with postoperative pulmonary complications in pediatric cardiac surgery, and minimizing the use of blood products may be beneficial. In addition, reducing the volume of priming fluid in the CPB circuit can reduce the decrease in hematocrit concentration associated from hemodilution. Besides reducing the priming volume, Retrograde Autologous Priming (RAP) and Reduced Priming (RP) can further reduce hemodilution associated with CPB initiation. Therefore, we investigated whether there was a correlation between the amount of RAP and the effect of reducing hematocrit decline, and whether there was a difference in the amount of RAP administered between cases that achieved bloodless surgery and cases that required intraoperative transfusion. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - 15 years-old > Gender - Male and Female Key inclusion criteria - Pediatric patients who underwent intracardiac repair for ventricular septal defect or atrial septal defect at Seirei Hamamatsu Hospital between January 2006 and December 2024. Key exclusion criteria - Cases where no transfusion surgery was deemed unfeasible and blood products were administered to the initial priming fluid of cardiopulmonary bypass beforehand Cases extracted from the database as ventricular septal defect and atrial septal defect, but where these were comorbid conditions and the primary pathology differed Cases where the surgical procedure was extended during surgery due to unexpected patient factors or complications Cases meeting the age criteria of 0 to 15 years old but with a weight exceeding 50 kg Cases where a lateral thoracotomy approach was chosen instead of a standard median sternotomy Emergency surgeries Target Size - 191

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 10 Month 10 Day Date of IRB - 2025 Year 12 Month 16 Day Anticipated trial start date - 2025 Year 12 Month 16 Day Last follow-up date - 2026 Year 01 Month 09 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067879

Disclaimer: Curated by HT Syndication.