The Influence of Blood Sampling Technique on the Total Amount of Blood Collected for Laboratory Testing Critically Ill Pediatric Patients

Not Applicable

Not yet recruiting

• Conditions: Iatrogenic Anaemia

• Registration Number: NCT06376747
• Lead Sponsor: Brno University Hospital

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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-17
• Last Update Submitted: 2024-04-17
• Study First Posted: 2024-04-19
• Last Update Posted: 2024-04-19
• Study Start: 2024-05-01
• Primary Completion: 2025-04-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Average amount of blood collected for laboratory diagnostic purposes	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

Secondary Outcome Measures

Name	Time	Method
Incidence of anaemia up to transfusion trigger	on the day of patient' s discharge from paediatric ICU	haemoglobin levels below 70 g/l at any time during hospitalization
Trend of haemoglobin decline over time	Ondays 1,3,5,7,10,14 and 28 of patient stay at paediatric ICU	Trend of haemoglobin decline over time, defined as the absolute value of haemoglobin
Incidence of anaemia	on the day of patient' s discharge from paediatric ICU	decrease in haemoglobin levels below 90 g/l at any time during hospitalization
Frequency of blood product transfusions and their quantity	on the day of patient' s discharge from paediatric ICU	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
Absolute amount of blood drawn and blood used for laboratory testing	On the day of patient' s discharge from paediatric ICU	Absolute amount of blood drawn and blood used for laboratory testing, relative to the patient's body weight, age, and day of ICU hospitalization
Incidence of coagulopathy	on the day of patient' s discharge from paediatric ICU	Incidence of coagulopathy defined as INR above 1.4 and/or aPTT above 1.5 and/or fibrinogen below 1.5 g/l
Incidence of catheter-related complications	on the day of patient' s discharge from paediatric ICU	Incidence of catheter-related complications catheter infections, catheter occlusion defined, accidental catheter withdrawal)
Cumulative amount of blood drawn per day of ICU hospitalization	On the day of patient' s discharge from paediatric ICU	Cumulative amount of blood drawn, relative to the patient's body weight and age, per day of ICU hospitalization
Type and frequency of laboratory tests	on the day of patient' s discharge from paediatric ICU	Type and frequency of laboratory tests noted on daily basis by ICU nursing stuff
Time to catheter replacement in case of catheter exchange	on the day of patient' s discharge from paediatric ICU	Time to catheter replacement in case of catheter exchange (in days)

Trial Locations

Locations (1)

KDAR - department of pediatrics anesthesia and resuscitation; 🇨🇿 Brno, Czechia