Clinical trial NCT06376747: The Influence of Blood Sampling Technique on the Total Amount of Blood Collected for Laboratory Testing Critically Ill Pediatric Patients
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Iatrogenic Anaemia
Keywords: Paediatric patient
Patient Blood Management
Paediatric ICU
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Average amount of blood collected for laboratory diagnostic purposes
timeFrame: On day 1,3,5,7,10,14 and 28 of patient stay at paediatric ICU
Secondary outcomes:
measure: Cumulative amount of blood drawn per day of ICU hospitalization
timeFrame: On the day of patient' s discharge from paediatric ICU
measure: Absolute amount of blood drawn and blood used for laboratory testing
timeFrame: On the day of patient' s discharge from paediatric ICU
measure: Trend of haemoglobin decline over time
timeFrame: Ondays 1,3,5,7,10,14 and 28 of patient stay at paediatric ICU
measure: Incidence of anaemia
timeFrame: on the day of patient' s discharge from paediatric ICU
measure: Incidence of anaemia up to transfusion trigger
timeFrame: on the day of patient' s discharge from paediatric ICU
measure: Frequency of blood product transfusions and their quantity
timeFrame: on the day of patient' s discharge from paediatric ICU
measure: Type and frequency of laboratory tests
timeFrame: on the day of patient' s discharge from paediatric ICU
measure: Incidence of coagulopathy
timeFrame: on the day of patient' s discharge from paediatric ICU
measure: Incidence of catheter-related complications
timeFrame: on the day of patient' s discharge from paediatric ICU
measure: Time to catheter replacement in case of catheter exchange
timeFrame: on the day of patient' s discharge from paediatric ICU
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: KDAR - department of pediatrics anesthesia and resuscitation
Study officials:
References: