Actively Recruiting
SISIPUSH: Evaluation of Hemolysis and Iatrogenic Anemia Using the Push-pull Method to Obtain Blood from Pediatric Patients with Central Venous Catheters
Led by University Hospital, Ghent · Updated on 2024-10-24
150
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
U
University Ghent
Collaborating Sponsor
AI-Summary
What this Trial Is About
Anemia commonly occurs during hospital stays in both adults and children, often worsened by repeated blood sampling which causes additional blood loss known as iatrogenic anemia. This effect is more significant in children due to their lower blood volume, making interventions to reduce blood sample frequency or volume particularly important. However, limited data exist on iatrogenic anemia development in hospitalized children, prompting this study to assess a new blood sampling method. The study compares the push-pull technique, a method that avoids discarding "waste blood" during blood sampling via central venous catheters, with the standard care method that requires discarding 5 to 10 ml of blood before collecting samples. Children hospitalized with central venous catheters are randomly assigned to either method for the remainder of their hospital stay. Nurses also rate the ease of use and satisfaction with each procedure. Participants will have data collected routinely from their medical records including the number of blood samples, hemoglobin levels, blood transfusions, markers of hemolysis, catheter type, and hospitalization reasons. The study monitors the changes in hemoglobin from randomization until hospital discharge or catheter removal. Secondary measures include hemolysis, anemia onset, blood sample quality, bacteremia, catheter function, and operator ease. The study aims to understand if the push-pull method can reduce anemia and complications during hospital stays in children.
CONDITIONS
Brief Title
SISIPUSH: Evaluation of Hemolysis and Iatrogenic Anemia Using the Push-pull Method to Obtain Blood from Pediatric Patients with Central Venous Catheters
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospitalized patient at the Specialist Pediatric Department of Ghent University Hospital
- Age 0 to 18 years
- Presence of a central venous catheter for diagnostic or therapeutic reasons, surgically or non-surgically placed
- Catheter must be patent with the ability to infuse fluids and collect blood from at least one lumen
- Clinical or radiographic confirmation of correct central position of the catheter tip
- Expected or planned to have at least one blood collection per week during hospitalization
You will not qualify if you...
- Presence of a bloodstream or catheter-related infection before or at the time of randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From randomization until discharge from the hospital or removal of the central venous catheter
Participants are randomly assigned to either the push-pull technique or the standard of care method to obtain blood using their central venous catheter. Blood collections occur during hospitalization.
Blood collection visits at least once per week during hospitalization
Trial Site Locations
Total: 1 location
1
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
Research Team
L
Levi Hoste, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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