Transfusion-related Acute Lung Injury: a Prospective Cohort Study in Critically Ill Children
Condition: Acute Lung Injury
MeSH terms: Lung Injury; Acute Lung Injury; Transfusion-Related Acute Lung Injury; Wounds and Injuries
Study type: Observational [Patient Registry]

Summary: 
      Transfusions cause more adverse events in children than in adults. Patients in pediatric
      intensive care units (PICU) are particularly exposed to transfusions of plasma-rich blood
      products (red blood cell (RBC), plasma and platelets) and the risk of adverse events after a
      transfusion is particularly high in this vulnerable population. Transfusion-related acute
      lung injury (TRALI), an acute inflammation of the lungs that impairs gas exchange leading to
      acute respiratory failure, is one of the 2 most deadly transfusion complications in the
      general population. There is limited evidence on TRALI incidence and impact in critically ill
      children. This reduces the awareness of PICU team for this complication, and makes the
      decision process to transfuse particularly difficult. Moreover, acute lung injury is highly
      prevalent in critically ill children. It is therefore complex to ascertain if the high
      frequency of respiratory deteriorations observed after a transfusion in PICU is explained by
      the transfusion itself or by the evolution of the patient's critical illness.

      The investigators will conduct a cohort study of consecutive transfused critically ill
      children, with a control group of matched non-transfused children. The primary objective is
      to determine if transfusion of RBC, plasma and/or platelets in PICU is an independent risk
      factor of TRALI, and to compare the respiratory evolution in the two matched (transfused and
      non-transfused) groups. The secondary objectives will include the determination of the
      incidence rate, risk factors and clinical impact of TRALI in transfused PICU patients. The
      investigators will study both "classic TRALI" and "delayed TRALI".
    

Detailed description: 
      Study Design This prospective cohort study will include all consecutive transfused patients
      admitted to the participating PICUs over a one-year period and a control group of matched
      non-transfused patients. The primary objectives will be assessed using the complete cohort of
      transfused and non-transfused patients. Secondary objectives will be studied in transfused
      patients.

      Outcomes The primary outcome measure is TRALI (definite, probable, and delayed TRALI) as
      defined in section. In the non-transfused patients, the definition of Acute Lung Injury will
      be the same as the one used as a criterion for defining TRALI, and the observation period
      will be a similar 72-h period, starting at the same time zero.

      Primary Objectives

        -  Objective #1a: to determine if the transfusion of RBC, plasma or platelets is an
           independent risk factor of TRALI in critically ill children.

        -  Objective #1b: to compare the progression of the respiratory function, in particular the
           SpO2/FiO2 ratio, in transfused and non-transfused PICU patients.

      Secondary Objectives

        -  Objective #2.a : To determine the incidence rate of classic (definite or probable) TRALI
           and of delayed TRALI in transfused PICU patients.

        -  Objective #2.b : To characterize the risk factors of classic (definite or probable)
           TRALI and of delayed TRALI in transfused PICU patients.

        -  Objective #2.c : To compare the progression of respiratory parameters after a 1st
           transfusion in PICU patients with classic TRALI, delayed TRALI, and without TRALI.

        -  Objective #2.d : To compare the outcomes of transfused PICU patients with and without
           classic (definite or probable) TRALI and delayed TRALI.

        -  Objective #2.e : To describe the inflammatory profile of PICU patients with definite,
           probable, and delayed TRALI.
    

Intervention name(s): Blood transfusion
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All children admitted to a participating PICU will be considered eligible for inclusion.
      
Biospecimen description: 
      Blood samples will be collected from patients with suspected TRALI in order to generate some
      hypotheses regarding underlying mechanisms associated with the different types of TRALI
      (objective #2.e), the plasma level of IL-1beta, IL-6, IL8, and IL-10 will be measured.
    
Keywords: Transfusion-related acute lung injury, Red Blood Cell