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| Name | Class |
|---|---|
| Canadian Blood Services | OTHER |
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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".
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
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transfused critically ill children | Any infusion of RBC, plasma or platelets will be considered a 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%). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood transfusion | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transfusion-related acute lung injury | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Length of PICU stay (days) | 28 days | |
| 28-day all cause mortality | 28 days | |
| Multiple organ dysfunction syndrome (MODS) |
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Inclusion Criteria:
Exclusion Criteria:
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All children admitted to a participating PICU will be considered eligible for inclusion.
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume Emeriaud, MD, PhD | St. Justine's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital | Calgary | Alberta | T3B 6A9 | Canada | ||
| Children's Hospital of Eastern Ontario |
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| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| D000073617 | Transfusion-Related Acute Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D065227 | Transfusion Reaction |
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| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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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.
| 28 days |
| Ottawa |
| Ontario |
| K1H 8L1 |
| Canada |
| St. Justine's Hospital | Montreal | Quebec | H3T 1C5 | Canada |
| Montreal Children's Hospital | Montreal | Quebec | H4A 3J1 | Canada |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007154 | Immune System Diseases |