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.
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.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Levi Hoste, MD, PhD, +32 9 332 35 40, levi.hoste@uzgent.be
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.
- Conditions
- Pediatrics, Central Venous Catheter
- 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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Push-pull technique Receives: Procedure: Push-pull technique |
| Control | Active comparator | Standard 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.
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)
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
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
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
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
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
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
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
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.
- First posted24 Oct 2024
- Study start14 Oct 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SISIPUSH: Evaluation of Hemolysis and Iatrogenic Anemia Using the Push-pull Method to Obtain Blood from Pediatric Patients with Central Venous Catheters
- ClinicalTrials.gov ID
- NCT06657534
- Acronym / sponsor ID
- SISIPUSH / ONZ-2024-0215
- Conditions
- Pediatrics, Central Venous Catheter
- Keywords
- push-pull technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Push-pull techniquePush-pull technique |
| Control | Active comparator | Procedure: SOC (Standard of care)Standard of care blood sampling method with waste blood |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- presence of a bloodstream or catheter related infection before or at the time of randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Push-pull techniquepush-pull technique as described by McBride et al, J Infus Nurs 2018 | Procedure or surgery | Intervention |
| SOC (Standard of care)Standard of care method to obtain blood with waste blood | Procedure or surgery | Control |
Primary outcome
Evolution of hemoglobin
Time frame: from randomization to discharge from the hospital or removal of the central venous catheter
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
8 secondary outcomes
Hemolysis
Time frame: from randomization to discharge from the hospital or removal of the central venous catheter
Anemia onset
Time frame: from randomization to discharge from the hospital or removal of the central venous catheter
Need for erytrocyte transfusion
Time frame: from randomization to discharge from the hospital or removal of the central venous catheter
Hemolytic samples
Time frame: from randomization to discharge from the hospital or removal of the central venous catheter
Failed blood samples
Time frame: from randomization to discharge from the hospital or removal of the central venous catheter
Bacteremia onset
Time frame: from randomization to discharge from the hospital or removal of the central venous catheter
Catheter dysfunction
Time frame: from randomization to discharge from the hospital or removal of the central venous catheter
Operator ease of use
Time frame: from randomization to discharge from the hospital or removal of the central venous catheter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: Yes. peer-reviewed publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.