AzTrials
AzTrials

PediatricsSISIPUSHNCT06657534

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

A study testing Push-pull technique in people with Pediatrics and Central Venous Catheter, run by University Hospital, Ghent at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 0 to 18 years
Conditions the study is for
Pediatrics, Central Venous Catheter
What is being tested?
Push-pull technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteBelgium
Study dates
14 Oct 2024to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Levi Hoste, MD, PhD contact

+32 9 332 35 40

levi.hoste@uzgent.be

Belgium1 site, 1 recruiting
  • Ghent University Hospital

    Ghent, 9000

    Levi Hoste, MD, PhD, +32 9 332 35 40, levi.hoste@uzgent.be

    Recruiting

Other trials in Belgium

About this study

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.

Read more

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.

Being tested
Push-pull technique, SOC (Standard of care)
Keywords
push-pull technique

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Push-pull techniqueProcedure or surgery

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

  • SOC (Standard of care)Procedure or surgery

    Standard of care method to obtain blood with waste blood

Study groups in NCT06657534
Study groupRoleWhat they receive
InterventionExperimentalPush-pull technique
Receives: Procedure: Push-pull technique
ControlActive comparatorStandard of care blood sampling method with waste blood
Receives: Procedure: SOC (Standard of care)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (8)
  1. Hemolysis

    analysis of hemolysis parameters on all blood samples (distribution of serum potassium and lactate dehydrogenase between the two study populations)

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

  2. Anemia onset

    proportion of patients diagnosed with anemia (hemoglobin <7 g/dl) during hospitalization

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

  3. 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

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

  4. Hemolytic samples

    proportion of blood samples reported by the clinical laboratory as hemolytic

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

  5. Failed blood samples

    proportion of blood samples that were not analyzable and reason for this (hemolysis or other)

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

  6. Bacteremia onset

    proportion of patients with bacteremia (positive blood culture) during the course of the study

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

  7. Catheter dysfunction

    proportion of patients in whom the central venous catheter had to be removed early due to dysfunction or infection

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

  8. Operator ease of use

    assessment of satisfaction (0-5) and complexity (0-5) of the procedure by the healthcare personnel performing the blood sampling

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2024
  2. Study start14 Oct 2024
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06657534
Sponsor's protocol ID
ONZ-2024-0215
Acronym
SISIPUSH
Status last verified
Oct 2024
First submitted
23 Oct 2024
Last updated
24 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: peer-reviewed publication

Questions about this trial

What is this clinical trial studying?

A study testing Push-pull technique in people with Pediatrics and Central Venous Catheter, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Levi Hoste, MD, PhD (+32 9 332 35 40, levi.hoste@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evolution of hemoglobin (time frame: from randomization to discharge from the hospital or removal of the central venous catheter). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in