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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Average amount of blood collected for laboratory diagnostic purposes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 1 Month 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Average amount of blood collected for laboratory diagnostic purposes
时间窗: 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
次要结局
- Incidence of anaemia up to transfusion trigger(on the day of patient' s discharge from paediatric ICU)
- Trend of haemoglobin decline over time(Ondays 1,3,5,7,10,14 and 28 of patient stay at paediatric ICU)
- Incidence of anaemia(on the day of patient' s discharge from paediatric ICU)
- Frequency of blood product transfusions and their quantity(on the day of patient' s discharge from paediatric ICU)
- Absolute amount of blood drawn and blood used for laboratory testing(On the day of patient' s discharge from paediatric ICU)
- Incidence of coagulopathy(on the day of patient' s discharge from paediatric ICU)
- Incidence of catheter-related complications(on the day of patient' s discharge from paediatric ICU)
- Cumulative amount of blood drawn per day of ICU hospitalization(On the day of patient' s discharge from paediatric ICU)
- Type and frequency of laboratory tests(on the day of patient' s discharge from paediatric ICU)
- Time to catheter replacement in case of catheter exchange(on the day of patient' s discharge from paediatric ICU)
研究者
Petr Štourač, MD
prof. Petr Stourac M.D., Ph.D., MBA, FESAIC
Brno University Hospital