Iatrogenic Anaemia
Conditions
Keywords
Paediatric patient, Patient Blood Management, Paediatric ICU
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.
Interventions
PROCEDUREIn line sampling
closed technique of sample collection
PROCEDUREStandard blood sampling technique
Blood draws using standard steps: blood withdrawal for catheter, decontamination (disposed),blood draw for laboratory analysis,catheter flush
Sponsors
Brno University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Masking description
Patients will be randomized into two groups: a group with standard blood sampling technique and a group with closed technique blood sampling by using randomizing software.
Eligibility
Sex/Gender
ALL
Age
1 Months to 19 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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) |
| 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 |
| 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 |
| 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 |
| 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) |
| 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 |
Countries
Czechia
Contacts
Primary ContactPetr Stourac, prof. M.D.,Ph.D., MBA, FESAIC
Backup ContactTamara Skrisovska, M.D.
Outcome results
None listed