SISIPUSH: Evaluation of Hemolysis and Iatrogenic Anemia Using the Push-pull Method to Obtain Blood from Pediatric Patients with Central Venous Catheters (SISIPUSH)

Anemia is frequently observed during hospitalizations, both in adults and children. In addition to the fact that anemia can be caused by an acute or chronic condition, blood samples taken during the hospital stay contribute to additional blood loss (so-called iatrogenic anemia).

For children, the relative amount of blood taken at each blood collection is greater than in adults. It is therefore expected that in children, due to the lower circulating blood volume, the relative impact of repeated blood sampling is greater and interventions such as sparing the number of blood samples or blood volume can have a relevant impact on the onset of anemia, the need for iron supplements or blood transfusions and the general clinical recovery.

For children, only limited data are available on the development of iatrogenic anemia during hospital stay. In a study of children in an intensive care unit, a decrease in hemoglobin of 0.7 g/dl can already be seen with an average stay of 4.5 days (and an average number of blood samples of 2.9) (François et al. Ped Crit Car Med, 2022). The average blood volume lost to blood samples during the stay is 3.9 ml/kg, which already corresponds to 5% of the total blood volume. Interventions to decrease the frequency of blood sampling or to perform the same analyses on a smaller blood volume (e.g. adapted, smaller blood tubes for children) are therefore useful in preventing the development of anemia during a hospital stay, especially in children.

Alternative methods have been described to save on blood volume when performing blood sampling, especially if these are performed via central venous catheters (surgically or non-surgically placed). To obtain a suitable sample via such catheters, the usual technique is to obtain 5 to 10 ml of blood and discard the volume (so-called "waste blood") before the sample for laboratory analysis is obtained (typically only 1-2 ml). A recently published technique is the so-called push-pull method (described by McBride et al, J Infus Nurs 2018), in which blood sampling can be performed without waste blood.

The push-pull technique has been studied in children, but mainly in oncological and intensive care units. Paired analyses have verified that the technique provides a reliable sample for most blood analyses, including blood count, electrolytes, liver and kidney function parameters, CRP, but also coagulation factors and therapeutic drug monitoring. The occurrence of complications, of which the development of catheter-related bacteremia is of particular importance, is not described. A beneficial effect on anemia onset has not yet been described, usually due to low patient numbers per study (23-35 patients).

In SISIPUSH, we compare the push-pull technique with the standard-of-care in hospitalised children who undergo blood sampling via a central venous catheter for diagnostic reasons (in the context of routine care). By means of a 1:1 randomization, eligible patients who gave informed consent are assigned to one of the two methods for the remainder of the hospitalization. From the moment of randomization until discharge from the hospital, data will be collected from the medical file that are collected routinely (number of blood samples, hemoglobin values, number of blood transfusions, markers of hemolysis, age and gender, reason for hospitalization, type of catheter) and compared between the two groups. In parallel, nurses score the easy of use and satisfaction with the procedure at each blood sample.

Study Overview

• Status: Recruiting
• Conditions: Pediatrics; Central Venous Catheter
• Intervention / Treatment: Procedure: Push-pull technique; Procedure: SOC (Standard of care)

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Levi Hoste, MD, PhD; Phone Number: +32 9 332 35 40; Email: levi.hoste@uzgent.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
    • Contact: Levi Hoste, MD, PhD; Phone Number: +32 9 332 35 40; Email: levi.hoste@uzgent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• hospitalized patient at the Specialist Pediatric Department of Ghent University Hospital
• age 0-18 years
• presence of a central venous catheter for diagnostic or therapeutic reasons of the type surgically placed (Hickman, port-a-cath) or non-surgically placed (vena jugularis interna, subclavia, femoralis,...)
• patent catheter with possibility of infusion of fluids and collection of blood on at least one of the lumens
• clinical and/or radiographic confirmation of correct central position of the catheter tip
• at least one blood collection per week hospitalization expected or already planned

Exclusion Criteria:

• presence of a bloodstream or catheter related infection before or at the time of randomization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Push-pull technique	Procedure: Push-pull technique; push-pull technique as described by McBride et al, J Infus Nurs 2018
Active Comparator: Control; Standard of care blood sampling method with waste blood	Procedure: SOC (Standard of care); Standard of care method to obtain blood with waste blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of hemoglobin	trend of hemoglobin (from the first blood draw after randomization to the last blood draw during the same hospitalization), which is defined as the sum of the negative differences of hemoglobin determinations (grams per deciliter) between two consecutive blood draws	from randomization to discharge from the hospital or removal of the central venous catheter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemolysis	analysis of hemolysis parameters on all blood samples (distribution of serum potassium and lactate dehydrogenase between the two study populations)	from randomization to discharge from the hospital or removal of the central venous catheter
Anemia onset	proportion of patients diagnosed with anemia (hemoglobin <7 g/dl) during hospitalization	from randomization to discharge from the hospital or removal of the central venous catheter
Need for erytrocyte transfusion	number of patients undergoing a packed red blood cell transfusion during hospitalization, expressed as proportion of patients compared to total number of patients, in number of transfusions per total number of blood samples and in number of transfusions per day of hospitalization since inclusion	from randomization to discharge from the hospital or removal of the central venous catheter
Hemolytic samples	proportion of blood samples reported by the clinical laboratory as hemolytic	from randomization to discharge from the hospital or removal of the central venous catheter
Failed blood samples	proportion of blood samples that were not analyzable and reason for this (hemolysis or other)	from randomization to discharge from the hospital or removal of the central venous catheter
Bacteremia onset	proportion of patients with bacteremia (positive blood culture) during the course of the study	from randomization to discharge from the hospital or removal of the central venous catheter
Catheter dysfunction	proportion of patients in whom the central venous catheter had to be removed early due to dysfunction or infection	from randomization to discharge from the hospital or removal of the central venous catheter
Operator ease of use	assessment of satisfaction (0-5) and complexity (0-5) of the procedure by the healthcare personnel performing the blood sampling	from randomization to discharge from the hospital or removal of the central venous catheter

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Ghent University, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: push-pull technique
• Additional Relevant MeSH Terms: Pathologic Processes; Hemolysis
• Other Study ID Numbers: ONZ-2024-0215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: peer-reviewed publication
• IPD Sharing Time Frame: January 2026
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No