Transfusion-related Acute Lung Injury: a Prospective Cohort Study in Critically Ill Children

NCT02613377 | Completed

• 1 other identifier: CHUSJ-MP-21-2016-1070
• Study Type: observational
• Target: 717
• Locations: 1 country
• Sites: 4

Brief 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".

Conditions

Acute Lung Injury

Keywords

Transfusion-related acute lung injury, Red Blood Cell

Outcome Measures

Primary Outcomes (1)

• Transfusion-related acute lung injury

  72 hours

Secondary Outcomes (3)

• Length of PICU stay (days)

  28 days

• 28-day all cause mortality

  28 days

• Multiple organ dysfunction syndrome (MODS)

  28 days

Study Arms (2)

Transfused critically ill children

Any infusion of RBC, plasma or platelets will be considered a transfusion.

Other: Blood transfusion

Non-transfused critically ill children

For each transfused patient (index patient), one matched non-transfused control will be identified and included in the control group. The matching will be conducted using four criteria in hierarchical order: gender; age ± 10%; baseline Hemoglobin level (± 15 g/L); and Pediatric Risk of Mortality III score (PRISM III score ± 10%).

Interventions

Blood transfusion OTHER

Transfused critically ill children

Eligibility Criteria

• Age: 3 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All children admitted to a participating PICU will be considered eligible for inclusion.

You may qualify if:

• admission to the PICU

You may not qualify if:

• gestational age \< 40 weeks at entry into PICU
• post-term age less than 3 days or more than 18 years at PICU admission
• patients on extra-corporeal membrane oxygenation or ventricular assist device
• pregnancy present at entry into the PICU
• admission to PICU just after labor

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Canadian Blood Services: collaborator

Study Sites (4)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A9, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

St. Justine's Hospital

Montreal, Quebec, H3T 1C5, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Acute Lung Injury; Transfusion-Related Acute Lung Injury

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Transfusion Reaction; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Guillaume Emeriaud, MD, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 24, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2021
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CA (4)