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

NCT02613377 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 717

Last updated 2023-04-18

No results posted yet for this study

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

Interventions

OTHER

Blood transfusion

Sponsors & Collaborators

  • Canadian Blood Services

    collaborator OTHER

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Guillaume Emeriaud, MD, PhD · St. Justine's Hospital

Eligibility

Min Age
3 Days
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2020-01-31
Completion
2021-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02613377 on ClinicalTrials.gov