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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Iatrogenic Anaemia
• Intervention / Treatment: Procedure: Standard blood sampling technique; Procedure: In line sampling

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Petr Stourac, prof. M.D.,Ph.D., MBA, FESAIC; Phone Number: +420532234698; Email: stourac.petr@fnbrno.cz
• Study Contact Backup: Name: Tamara Skrisovska, M.D.; Phone Number: +420532234698; Email: skrisovska.tamara@fnbrno.cz

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • KDAR - department of pediatrics anesthesia and resuscitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard blood sampling technique; Blood withdrawal after catheter decontamination, blood draw for laboratory analysis, catheter flush	Procedure: Standard blood sampling technique; Blood draws using standard steps: blood withdrawal for catheter, decontamination (disposed),blood draw for laboratory analysis,catheter flush
Experimental: Closed technique blood sampling; 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	Procedure: In line sampling; closed technique of sample collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	On day 1,3,5,7,10,14 and 28 of patient stay at paediatric ICU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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)	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)	on the day of patient' s discharge from paediatric ICU

Collaborators and Investigators

• Sponsor: Brno University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Patient Blood Management; Paediatric patient; Paediatric ICU
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: KDAR- PBM 2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No