Iatrogenic AnaemiaPEDPBMNCT06376747
The Influence of Blood Sampling Technique on the Total Amount of Blood Collected for Laboratory Testing Critically Ill Pediatric Patients
A study testing In line sampling and Standard blood sampling technique in people with Iatrogenic Anaemia, run by Brno University Hospital at 1 site in Czechia.
Trial summary
The aim of this prospective randomized study is to evaluate blood loss caused by laboratory blood draws in patients in the paediatric ICU (Intensive Care Unit) of a tertiary hospital among two groups of patients with established long-term or mid-term intravenous access. Read more about this study
- Who is it for?
- Ages 1 month to 19 years
- Conditions the study is for
- Iatrogenic Anaemia
- What is being tested?
- In line sampling and Standard blood sampling technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2024to 31 Aug 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 1 month to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed informed consent for the study.
- Patients with established intravenous access: CVC (Central Venous Catheter), CICC (Centrally Inserted Central Catheter), PICC (Peripherally Inserted Central Catheter), MVC (Midline Venous Catheter), venous port, from which blood can be drawn.
- Anticipated length of stay in the ICU more than 24 hours
Who cannot join
- Age outside the specified range.
- Peripheral venous access only.
- Anticipated length of stay in the ICU less than 24 hours.
- Organ donors.
- Lack of consent from the legal representative/patient.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
KDAR - department of pediatrics anesthesia and resuscitation
Brno, 62500
About this study
Official title: The Influence of Blood Sampling Technique on the Total Amount of Blood Collected for Laboratory Testing in Critically Ill Pediatric Patients: a Prospective Randomized Study
The aim of this prospective randomized study is to evaluate blood loss caused by laboratory blood draws in patients in the paediatric ICU (Intensive Care Unit) of a tertiary hospital among two groups of patients with established long-term or mid-term intravenous access. In the first group, patients will undergo blood draws using the standard method. In the second group of patients, blood draws will be performed using a closed system.
Read the detailed description
Anaemia is one of the most common comorbidities among patients hospitalized in intensive care units. Hospital-acquired anaemia (HAA) is a newly developed anaemia that occurs during hospitalization in patients who were not anaemic prior to admission. Patients with HAA have a higher risk of developing complications such as infections, muscle weakness, and neurocognitive developmental disorders; an increased incidence of blood and blood product transfusions (and related complications); longer hospital stays, and higher morbidity and mortality. According to available data, the incidence of anaemia in adults hospitalized in the ICU ranges from 40 to 74%. There a feq data describing anemia in critically ill pediatric patients, with the estimated incidence being up to 50%.
The etiology of HAA is multifactorial and is related to the severity of the underlying disease (sepsis, coagulation disorders, bleeding, renal failure, malnutrition, bone marrow suppression, decreased erythropoietin production, etc.). Another factor contributing to the development of anaemia in critically ill patients is iatrogenic blood loss caused by blood draws for laboratory testing.
In addition to the standard blood collection method, closed-loop sampling (in-line sampling) can also be used, with studies in adult patients showing a reduction in the amount of blood drawn, ranging from 20 to 80% after its implementation.
- Conditions
- Iatrogenic Anaemia
- Being tested
- In line sampling, Standard blood sampling technique
- Keywords
- Paediatric patient, Patient Blood Management, Paediatric ICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In line samplingProcedure or surgery
closed technique of sample collection
Standard blood sampling techniqueProcedure or surgery
Blood draws using standard steps: blood withdrawal for catheter, decontamination (disposed),blood draw for laboratory analysis,catheter flush
| Study group | Role | What they receive |
|---|---|---|
| Standard blood sampling technique | Active comparator | Blood withdrawal after catheter decontamination, blood draw for laboratory analysis, catheter flush Receives: Procedure: Standard blood sampling technique |
| Closed technique blood sampling | Experimental | In-line sampling: through 2 three-way stopcocks: blood withdrawal for catheter decontamination, blood draw for laboratory analysis, return of the withdrawn blood for catheter decontamination, catheter flush Receives: Procedure: In line sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average amount of blood collected for laboratory diagnostic purposes
Average amount of blood collected for laboratory diagnostic purposes on days 1, 3, 5, 7, 10, 14, and 28 of hospitalization in two groups of patients subjected to different blood sampling techniques for laboratory testing
Measured: On day 1,3,5,7,10,14 and 28 of patient stay at paediatric ICU
Secondary outcomes (10)
Cumulative amount of blood drawn per day of ICU hospitalization
Cumulative amount of blood drawn, relative to the patient's body weight and age, per day of ICU hospitalization
Measured: On the day of patient' s discharge from paediatric ICU
Absolute amount of blood drawn and blood used for laboratory testing
Absolute amount of blood drawn and blood used for laboratory testing, relative to the patient's body weight, age, and day of ICU hospitalization
Measured: On the day of patient' s discharge from paediatric ICU
Trend of haemoglobin decline over time
Trend of haemoglobin decline over time, defined as the absolute value of haemoglobin
Measured: Ondays 1,3,5,7,10,14 and 28 of patient stay at paediatric ICU
Incidence of anaemia
decrease in haemoglobin levels below 90 g/l at any time during hospitalization
Measured: on the day of patient' s discharge from paediatric ICU
Incidence of anaemia up to transfusion trigger
haemoglobin levels below 70 g/l at any time during hospitalization
Measured: on the day of patient' s discharge from paediatric ICU
Frequency of blood product transfusions and their quantity
Frequency of blood product transfusions (erythrocytes, platelets, plasma, fibrinogen, and other coagulation factors) and their quantity relative to the patient's body weight and age
Measured: on the day of patient' s discharge from paediatric ICU
Type and frequency of laboratory tests
Type and frequency of laboratory tests noted on daily basis by ICU nursing stuff
Measured: on the day of patient' s discharge from paediatric ICU
Incidence of coagulopathy
Incidence of coagulopathy defined as INR above 1.4 and/or aPTT above 1.5 and/or fibrinogen below 1.5 g/l
Measured: on the day of patient' s discharge from paediatric ICU
Incidence of catheter-related complications
Incidence of catheter-related complications catheter infections, catheter occlusion defined, accidental catheter withdrawal)
Measured: on the day of patient' s discharge from paediatric ICU
Time to catheter replacement in case of catheter exchange
Time to catheter replacement in case of catheter exchange (in days)
Measured: on the day of patient' s discharge from paediatric ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iatrogenic AnaemiaStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376747
- Sponsor's protocol ID
- KDAR- PBM 2024
- Acronym
- PEDPBM
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Blood Sampling Technique on the Total Amount of Blood Collected for Laboratory Testing in Critically Ill Pediatric Patients: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06376747
- Acronym / sponsor ID
- PEDPBM / KDAR- PBM 2024
- Conditions
- Iatrogenic Anaemia
- Keywords
- Paediatric patient, Patient Blood Management, Paediatric ICU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 19 Apr 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.
The aim of this prospective randomized study is to evaluate blood loss caused by laboratory blood draws in patients in the paediatric ICU (Intensive Care Unit) of a tertiary hospital among two groups of patients with established long-term or mid-term intravenous access. In the first group, patients will undergo blood draws using the standard method. In the second group of patients, blood draws will be performed using a closed system.
Detailed description
Anaemia is one of the most common comorbidities among patients hospitalized in intensive care units. Hospital-acquired anaemia (HAA) is a newly developed anaemia that occurs during hospitalization in patients who were not anaemic prior to admission. Patients with HAA have a higher risk of developing complications such as infections, muscle weakness, and neurocognitive developmental disorders; an increased incidence of blood and blood product transfusions (and related complications); longer hospital stays, and higher morbidity and mortality. According to available data, the incidence of anaemia in adults hospitalized in the ICU ranges from 40 to 74%. There a feq data describing anemia in critically ill pediatric patients, with the estimated incidence being up to 50%.
The etiology of HAA is multifactorial and is related to the severity of the underlying disease (sepsis, coagulation disorders, bleeding, renal failure, malnutrition, bone marrow suppression, decreased erythropoietin production, etc.). Another factor contributing to the development of anaemia in critically ill patients is iatrogenic blood loss caused by blood draws for laboratory testing.
In addition to the standard blood collection method, closed-loop sampling (in-line sampling) can also be used, with studies in adult patients showing a reduction in the amount of blood drawn, ranging from 20 to 80% after its implementation.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard blood sampling technique | Active comparator | Procedure: Standard blood sampling techniqueBlood withdrawal after catheter decontamination, blood draw for laboratory analysis, catheter flush |
| Closed technique blood sampling | Experimental | Procedure: In line samplingIn-line sampling: through 2 three-way stopcocks: blood withdrawal for catheter decontamination, blood draw for laboratory analysis, return of the withdrawn blood for catheter decontamination, catheter flush |
Who may qualify
- Ages
- 1 month to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Signed informed consent for the study.
- Patients with established intravenous access: CVC (Central Venous Catheter), CICC (Centrally Inserted Central Catheter), PICC (Peripherally Inserted Central Catheter), MVC (Midline Venous Catheter), venous port, from which blood can be drawn.
- Anticipated length of stay in the ICU more than 24 hours
Key exclusion criteria (5 listed)
- Age outside the specified range.
- Peripheral venous access only.
- Anticipated length of stay in the ICU less than 24 hours.
- Organ donors.
- Lack of consent from the legal representative/patient.
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 |
|---|---|---|
| In line samplingclosed technique of sample collection | Procedure or surgery | Closed technique blood sampling |
| Standard blood sampling techniqueBlood draws using standard steps: blood withdrawal for catheter, decontamination (disposed),blood draw for laboratory analysis,catheter flush | Procedure or surgery | Standard blood sampling technique |
Primary outcome
Average amount of blood collected for laboratory diagnostic purposes
Time frame: On day 1,3,5,7,10,14 and 28 of patient stay at paediatric ICU
Average amount of blood collected for laboratory diagnostic purposes on days 1, 3, 5, 7, 10, 14, and 28 of hospitalization in two groups of patients subjected to different blood sampling techniques for laboratory testing
10 secondary outcomes
Cumulative amount of blood drawn per day of ICU hospitalization
Time frame: On the day of patient' s discharge from paediatric ICU
Absolute amount of blood drawn and blood used for laboratory testing
Time frame: On the day of patient' s discharge from paediatric ICU
Trend of haemoglobin decline over time
Time frame: Ondays 1,3,5,7,10,14 and 28 of patient stay at paediatric ICU
Incidence of anaemia
Time frame: on the day of patient' s discharge from paediatric ICU
Incidence of anaemia up to transfusion trigger
Time frame: on the day of patient' s discharge from paediatric ICU
Frequency of blood product transfusions and their quantity
Time frame: on the day of patient' s discharge from paediatric ICU
Type and frequency of laboratory tests
Time frame: on the day of patient' s discharge from paediatric ICU
Incidence of coagulopathy
Time frame: on the day of patient' s discharge from paediatric ICU
Incidence of catheter-related complications
Time frame: on the day of patient' s discharge from paediatric ICU
Time to catheter replacement in case of catheter exchange
Time frame: on the day of patient' s discharge from paediatric ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Iatrogenic Anaemia
Recruiting
Closed-blood Sampling Devices in the Adult Critically Ill Patient
Acceptability of Health Care
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 In line sampling and Standard blood sampling technique in people with Iatrogenic Anaemia, run by Brno University Hospital at 1 site in Czechia.
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 3 inclusion and 5 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 19 Apr 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 Czechia. 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 Petr Stourac, prof. M.D.,Ph.D., MBA, FESAIC (+420532234698, stourac.petr@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average amount of blood collected for laboratory diagnostic purposes (time frame: On day 1,3,5,7,10,14 and 28 of patient stay at paediatric ICU). 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 19 Apr 2024.