Acute Lung InjuryTRALINCT02613377
Transfusion-related Acute Lung Injury: a Prospective Cohort Study in Critically Ill Children
An observational study of Acute Lung Injury, run by St. Justine's Hospital at 4 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 days to 18 years
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- Blood transfusion
- Type of treatment
- Injection or infusion
- How many people
- 717 participants
- Where
- 4 sitesCanada
- Study dates
- Jan 2016to Dec 2021
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children admitted to a participating PICU will be considered eligible for inclusion.
Who may be able to join
- admission to the PICU
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A9
St. Justine's Hospital
Montreal, Quebec, H3T 1C5
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
About this study
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".
Read the 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.
- Conditions
- Acute Lung Injury
- Being tested
- Blood transfusion
- Keywords
- Transfusion-related acute lung injury, Red Blood Cell
- Medical subject headings
- Acute Lung Injury, Transfusion-Related Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood transfusionOther
| Study group | Role | What they receive |
|---|---|---|
| Transfused critically ill children | Any infusion of RBC, plasma or platelets will be considered a transfusion. Receives: 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%). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion-related acute lung injury
Measured: 72 hours
Secondary outcomes (3)
Length of PICU stay (days)
Measured: 28 days
28-day all cause mortality
Measured: 28 days
Multiple organ dysfunction syndrome (MODS)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2020
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 717 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Blood Services
- Responsible party
- Principal investigator, Dr Guillaume Emeriaud, St. Justine's Hospital
- Investigators
- Guillaume Emeriaud, MD, PhD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613377
- Sponsor's protocol ID
- CHUSJ-MP-21-2016-1070
- Acronym
- TRALI
- Status last verified
- Apr 2023
- First submitted
- 20 Nov 2015
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion-related Acute Lung Injury: a Prospective Cohort Study in Critically Ill Children
- ClinicalTrials.gov ID
- NCT02613377
- Acronym / sponsor ID
- TRALI / CHUSJ-MP-21-2016-1070
- Conditions
- Acute Lung Injury
- Keywords
- Transfusion-related acute lung injury, Red Blood Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 717 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Canadian Blood Services
- Study start
- Jan 2016
- Primary completion
- Jan 2020 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transfused critically ill children | – | Other: Blood transfusionAny 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%). |
Who may qualify
- Ages
- 3 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children admitted to a participating PICU will be considered eligible for inclusion.
Key inclusion criteria (1 listed)
- admission to the PICU
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood transfusion | Other | Transfused critically ill children |
Primary outcome
Transfusion-related acute lung injury
Time frame: 72 hours
3 secondary outcomes
Length of PICU stay (days)
Time frame: 28 days
28-day all cause mortality
Time frame: 28 days
Multiple organ dysfunction syndrome (MODS)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Emeriaud, MD, PhD principal investigator
St. Justine's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lung Injury, run by St. Justine's Hospital at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transfusion-related acute lung injury (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.