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

NCT06657534 | Recruiting

• 1 other identifier: ONZ-2024-0215
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatrics; Central Venous Catheter

Keywords

push-pull technique

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Hemolysis

  from randomization to discharge from the hospital or removal of the central venous catheter

• Anemia onset

  from randomization to discharge from the hospital or removal of the central venous catheter

• Need for erytrocyte transfusion

  from randomization to discharge from the hospital or removal of the central venous catheter

• Hemolytic samples

  from randomization to discharge from the hospital or removal of the central venous catheter

• Failed blood samples

  from randomization to discharge from the hospital or removal of the central venous catheter

Study Arms (2)

Intervention

EXPERIMENTAL

Push-pull technique

Procedure: Push-pull technique

Control

ACTIVE COMPARATOR

Standard of care blood sampling method with waste blood

Procedure: SOC (Standard of care)

Interventions

Push-pull technique PROCEDURE

push-pull technique as described by McBride et al, J Infus Nurs 2018

Intervention

SOC (Standard of care) PROCEDURE

Standard of care method to obtain blood with waste blood

Control

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Levi Hoste, MD, PhD

CONTACT

+32 9 332 35 40; levi.hoste@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: October 14, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 31, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: January 2026

Locations

BE (1)