Transfusion-Related Acute Lung InjuryCURIENCT06444750
Comparison of the Proteome in ICU Patients in Search for TRALI Biomarkers: A Case-control Study Using Both Retrospective and Prospective Samples
An observational study of Transfusion-Related Acute Lung Injury and ARDS, Human, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Trial summary
Transfusion-related acute lung injury (TRALI) is a severe complication of blood transfusions. After a transfusion, TRALI develops in 0.08-15% of cases depending on the characteristics of the studied population. Due to preventive measures the incidence has decreased. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transfusion-Related Acute Lung Injury, ARDS, Human
- What is being tested?
- Blood sample collection
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to May 2027
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Samples from twenty TRALI patients are already available at Sanquin Blood Bank. These samples have been collected within 24 hours after TRALI onset. The only clinical data available for these samples is sex and age. This is our study group. As control we will include ICU patients in University Medical Center (UMC): * Patients without lung injury receiving a blood transfusion; * Patients with indirect ARDS receiving a blood transfusion; * Patients with pneumonia receiving a blood transfusion; * Patients with indirect ARDS, who do not receive a blood transfusion; * Patients with pneumonia who do not receive a blood transfusion; * Healthy volunteers recruited through Sanquin's donor system
Who may be able to join
- Patients on the ICU:
- Without lung injury who received a red blood cell (RBC) or platelet transfusion (PLT).
- With indirect ARDS with and without a blood transfusion (RBC or PLT);
- With pneumonia, with and without a blood transfusion (RBC or PLT).
Who cannot join
- "Objection to registration of data for scientific use" as noted in the patient file.
- Patients in whom it is impossible to obtain blood samples.
- Patients with massive hemorrhage.
- Patients with ARDS due to multiple transfusions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Transfusion-related acute lung injury (TRALI) is a severe complication of blood transfusions. After a transfusion, TRALI develops in 0.08-15% of cases depending on the characteristics of the studied population. Due to preventive measures the incidence has decreased. However, the incidence of TRALI is 50-100 times higher in critically ill patients compared to the general hospital population. Since the absolute incidence of respiratory transfusion complications is low and TRALI is under-diagnosed and - reported, to this date is has not been possible to elucidate the exact pathophysiology of TRALI. Consequently, no biomarkers are yet known to detect TRALI. This study aims to identify TRALI biomarkers, gain insight in cellular pathways underlying TRALI development and the role of neutrophils and regulatory T cells, which could enhance transfusion safety.
Read the detailed description
Objective of the study:
- To identify biomarkers specific for TRALI, thus aiding in future diagnostics of TRALI.
- To investigate the proteome in TRALI patients and thus gain knowledge on TRALI pathophysiology. This knowledge can be used to investigate preventive measures and therapy for TRALI.
- To investigate the role of neutrophils and regulatory T cells in TRALI, which are thought to be essential dysregulated in the in TRALI pathogenesis.
Study design:
Case-control study using retrospective and prospective samples. Samples available from known TRALI patients stored at Sanquin Blood Bank will be compared to samples from intensive care patients with acute respiratory distress syndrome (ARDS), pneumonia, or without lung injury and to samples of healthy volunteers. The treating physician will screen ICU patients for eligibility for one of our groups and asks for permission to be approached by a researcher for informed consent. After obtaining informed consent, patients will be allocated to a group depending on whether they need a transfusion. After admission and informed consent extra blood samples (30ml) will be drawn from patients within 24 hours of arrival.
For Group 1 (patients who receive a transfusion but do not have lung injury), Group 2 (patients who receive a transfusion and have indirect ARDS), and Group 3 (patients who receive a transfusion with pneumonia (local lung injury)) a second tube blood sample (30ml) will be drawn 12 hours after the first transfusion. We will collect two samples (max 60 mL) for this group to analyze the effect of transfusion on the proteome. Together with the clinical data we will search for TRALI biomarkers.
Study population:
Adult intensive care patient who are admitted with:
Pneumonia (without ARDS), indirect ARDS or no pulmonary injury with and wihtout receiving a blood transfusion.
Healthy volunteers obtained through the Sanquin donor system. The TRALI samples that are obtained through hemovigilance at Sanquin (see protocol 4.1).
Primary study parameters/outcome of the study:
The primary endpoint of this study is to identify TRALI-specific biomarkers by comparing plasma proteomic profiles between the following groups: TRALI patients, indirect ARDS patients (with and without transfusion), pneumonia patients (with and without transfusion), and healthy volunteers. To isolate the impact of transfusion on the proteome and differentiate it from TRALI-specific changes, we will also analyze proteomic profiles before and after transfusion in relevant groups. This approach aims to increase the specificity and sensitivity of identified protein biomarkers for accurate TRALI diagnosis and facilitate the development of novel diagnostic assays.
Secundary study parameters/outcome of the study (if applicable):
The secundary outcomes of this study are:
- Characterizing the TRALI Proteome: we will perform in-depth characterization of the proteome in TRALI patients to gain a comprehensive understanding of the molecular mechanisms underlying TRALI pathophysiology. This analysis aims to uncover potential therapeutic targets and pathways involved in TRALI development.
- Investigating Neutrophil and Treg responses: we will investigate the phenotype, activation status, and functional responses of neutrophils and Tregs in TRALI patients compared to relevant control groups. This detailed analysis will shed light on the roles of neutrophils and Tregs in TRALI pathogenesis.
- Conditions
- Transfusion-Related Acute Lung Injury, ARDS, Human
- Being tested
- Blood sample collection
- Keywords
- Transfusion-Related Acute Lung Injury, Proteomics, Intensive Care Unit, Critical Ill patients
- Medical subject headings
- Transfusion-Related Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionOther
Also called Blood draw
Blood samples of 30 mL will be collected at admission. For the groups that receive a blood transfusion an extra 30 mL blood sample will be collected.
| Study group | Role | What they receive |
|---|---|---|
| ICU patients who receive a transfusion without lung injury | Purpose: This group is critical for comparing the baseline effects of blood transfusion on the proteome in critically ill patients who do not develop lung injury Following transfusion, providing a control to differentiate between transfusion-related changes in the blood composition and the specific lung injury observed in TRALI. Understanding these changes will help identify biomarkers and mechanisms exclusive to TRALI. Research question: How do transfusion-related proteomic changes manifest in ICU patients who do not develop lung injury after transfusion, and how does this baseline differ from the proteomics of TRALI patients? Receives: Other: Blood sample collection | |
| ICU patients who receive a transfusion and have indirect ARDS | Purpose: By excluding patients with ARDS due to a pulmonary cause, this group isolates systemic, non-pulmonary factors that trigger lung injury from local pulmonary responses.
Comparing this with TRALI helps us pinpoint unique biomarkers and understand the role of plasma proteins and various cellular-pathways dealing with systemic inflammation with concomitant lung injury. Research question: What distinct proteomic profiles and cellular pathways in non-pulmonary ARDS are observed in comparison with TRALI? Receives: Other: Blood sample collection | |
| ICU patients who receive a transfusion and have infectious pneumonia | Purpose: Since both TRALI and pneumonia involve lung injury, understanding the differences in these responses will provide insight into the mechanisms responsible for lung inflammation in TRALI, distinguishing it from the lung inflammation caused by local pulmonary infection.
Research question: Can we differentiate between the immune and proteomic responses in localized infectious lung injury and transfusion-induced TRALI, exposing how the immune system reacts to an infection versus a transfusion event? Receives: Other: Blood sample collection | |
| ICU patients without transfusion and with indirect ARDS | Purpose: This group allows us to characterize the proteomic and immunological responses of ARDS independent of transfusion events. This comparison with TRALI aids in the identification of changes solely due to transfusion-induced acute lung injury. Research question: What are the unique blood signatures in indirect ARDS patients when transfusion factors are removed from the equation? Receives: Other: Blood sample collection | |
| Patients without transfusion and with infectious pneumonia | Purpose: Including this group clarifies the distinction between changes driven by infection and those unique to transfusion. By subtracting the effects of infectious responses, we can confirm that biomarkers are related specifically to TRALI. ABR 86798 CURIE study Version 5,April, 2025 16 of 35 Research question: How do the inflammatory cell and protein responses to localized lung infections compare to those induced by TRALI, ensuring biomarkers identified are specific to transfusion-related injury? Receives: Other: Blood sample collection | |
| Healthy volunteers | Purpose: The inclusion of healthy volunteers in this study is crucial. They provide a baseline of normal physiological and immunological steady-state composition of the blood, allowing us to identify biomarkers specific to TRALI and the other patient subgroups by accounting for baseline variability. This group serves as a valuable control for confounding factors such as critical illness (for which ICU admission), or pre-existing lung injury or concomitant systemic inflammation including the lung (ARDS), which might otherwise obscure the identification of TRALI-specific changes. This enhances data analysis and provides clarity in distinguishing potentially unique pathophysiologic mechanisms in TRALI.
Research question:
What baseline levels of protein, immune, and cellular profiles in healthy individuals differ from those in ICU patients undergoing transfusion, particular in terms of neutrophil activity, Treg function, and overall inflammation Receives: Other: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers for TRALI
The primary endpoint of this study is to identify TRALI-specific biomarkers by comparing plasma proteomic profiles between the following groups: TRALI patients, indirect ARDS patients (with and without transfusion), pneumonia patients (with and without transfusion), and healthy volunteers. To isolate the impact of transfusion on the proteome and differentiate it from TRALI-specific changes, we will also analyze proteomic profiles before and after transfusion in relevant groups. This approach aims to increase the specificity and sensitivity of identified protein biomarkers for accurate TRALI diagnosis and facilitate the development of novel diagnostic assays
Measured: From admission to the end of data collection (30 days)
Secondary outcomes (2)
Characterizing the TRALI proteome
We will perform in-depth characterization of the proteome in TRALI patients to gain a comprehensive understanding of the molecular mechanisms underlying TRALI pathophysiology. This analysis aims to uncover potential therapeutic targets and pathways involved in TRALI development.
Measured: From admission to the end of data collection (30 days)
Investigating Neutrophil and Treg responses
We will investigate the phenotype, activation status, and functional responses of neutrophils and Tregs in TRALI patients compared to relevant control groups. This detailed analysis will shed light on the roles of neutrophils and Tregs in TRALI pathogenesis.
Measured: From admission to the end of data collection (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfusion-Related 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A.P.J. Vlaar, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Alexander Vlaar, Professor, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444750
- Sponsor's protocol ID
- CURIE
- Acronym
- CURIE
- Status last verified
- Aug 2025
- First submitted
- 31 May 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Proteome in ICU Patients in Search for TRALI Biomarkers: A Case-control Study Using Both Retrospective and Prospective Samples
- ClinicalTrials.gov ID
- NCT06444750
- Acronym / sponsor ID
- CURIE / CURIE
- Conditions
- Transfusion-Related Acute Lung Injury, ARDS, Human
- Keywords
- Transfusion-Related Acute Lung Injury, Proteomics, Intensive Care Unit, Critical Ill patients
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 Jun 2024 (actual)
- 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.
Transfusion-related acute lung injury (TRALI) is a severe complication of blood transfusions. After a transfusion, TRALI develops in 0.08-15% of cases depending on the characteristics of the studied population. Due to preventive measures the incidence has decreased. However, the incidence of TRALI is 50-100 times higher in critically ill patients compared to the general hospital population. Since the absolute incidence of respiratory transfusion complications is low and TRALI is under-diagnosed and - reported, to this date is has not been possible to elucidate the exact pathophysiology of TRALI. Consequently, no biomarkers are yet known to detect TRALI. This study aims to identify TRALI biomarkers, gain insight in cellular pathways underlying TRALI development and the role of neutrophils and regulatory T cells, which could enhance transfusion safety.
Detailed description
Objective of the study:
- To identify biomarkers specific for TRALI, thus aiding in future diagnostics of TRALI.
- To investigate the proteome in TRALI patients and thus gain knowledge on TRALI pathophysiology. This knowledge can be used to investigate preventive measures and therapy for TRALI.
- To investigate the role of neutrophils and regulatory T cells in TRALI, which are thought to be essential dysregulated in the in TRALI pathogenesis.
Study design:
Case-control study using retrospective and prospective samples. Samples available from known TRALI patients stored at Sanquin Blood Bank will be compared to samples from intensive care patients with acute respiratory distress syndrome (ARDS), pneumonia, or without lung injury and to samples of healthy volunteers. The treating physician will screen ICU patients for eligibility for one of our groups and asks for permission to be approached by a researcher for informed consent. After obtaining informed consent, patients will be allocated to a group depending on whether they need a transfusion. After admission and informed consent extra blood samples (30ml) will be drawn from patients within 24 hours of arrival.
For Group 1 (patients who receive a transfusion but do not have lung injury), Group 2 (patients who receive a transfusion and have indirect ARDS), and Group 3 (patients who receive a transfusion with pneumonia (local lung injury)) a second tube blood sample (30ml) will be drawn 12 hours after the first transfusion. We will collect two samples (max 60 mL) for this group to analyze the effect of transfusion on the proteome. Together with the clinical data we will search for TRALI biomarkers.
Study population:
Adult intensive care patient who are admitted with:
Pneumonia (without ARDS), indirect ARDS or no pulmonary injury with and wihtout receiving a blood transfusion.
Healthy volunteers obtained through the Sanquin donor system. The TRALI samples that are obtained through hemovigilance at Sanquin (see protocol 4.1).
Primary study parameters/outcome of the study:
The primary endpoint of this study is to identify TRALI-specific biomarkers by comparing plasma proteomic profiles between the following groups: TRALI patients, indirect ARDS patients (with and without transfusion), pneumonia patients (with and without transfusion), and healthy volunteers. To isolate the impact of transfusion on the proteome and differentiate it from TRALI-specific changes, we will also analyze proteomic profiles before and after transfusion in relevant groups. This approach aims to increase the specificity and sensitivity of identified protein biomarkers for accurate TRALI diagnosis and facilitate the development of novel diagnostic assays.
Secundary study parameters/outcome of the study (if applicable):
The secundary outcomes of this study are:
- Characterizing the TRALI Proteome: we will perform in-depth characterization of the proteome in TRALI patients to gain a comprehensive understanding of the molecular mechanisms underlying TRALI pathophysiology. This analysis aims to uncover potential therapeutic targets and pathways involved in TRALI development.
- Investigating Neutrophil and Treg responses: we will investigate the phenotype, activation status, and functional responses of neutrophils and Tregs in TRALI patients compared to relevant control groups. This detailed analysis will shed light on the roles of neutrophils and Tregs in TRALI pathogenesis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ICU patients who receive a transfusion without lung injury | – | Other: Blood sample collectionPurpose: This group is critical for comparing the baseline effects of blood transfusion on the proteome in critically ill patients who do not develop lung injury Following transfusion, providing a control to differentiate between transfusion-related changes in the blood composition and the specific lung injury observed in TRALI. Understanding these changes will help identify biomarkers and mechanisms exclusive to TRALI. Research question: How do transfusion-related proteomic changes manifest in ICU patients who do not develop lung injury after transfusion, and how does this baseline differ from the proteomics of TRALI patients? |
| ICU patients who receive a transfusion and have indirect ARDS | – | Other: Blood sample collectionPurpose: By excluding patients with ARDS due to a pulmonary cause, this group isolates systemic, non-pulmonary factors that trigger lung injury from local pulmonary responses. Comparing this with TRALI helps us pinpoint unique biomarkers and understand the role of plasma proteins and various cellular-pathways dealing with systemic inflammation with concomitant lung injury. Research question: What distinct proteomic profiles and cellular pathways in non-pulmonary ARDS are observed in comparison with TRALI? |
| ICU patients who receive a transfusion and have infectious pneumonia | – | Other: Blood sample collectionPurpose: Since both TRALI and pneumonia involve lung injury, understanding the differences in these responses will provide insight into the mechanisms responsible for lung inflammation in TRALI, distinguishing it from the lung inflammation caused by local pulmonary infection. Research question: Can we differentiate between the immune and proteomic responses in localized infectious lung injury and transfusion-induced TRALI, exposing how the immune system reacts to an infection versus a transfusion event? |
| ICU patients without transfusion and with indirect ARDS | – | Other: Blood sample collectionPurpose: This group allows us to characterize the proteomic and immunological responses of ARDS independent of transfusion events. This comparison with TRALI aids in the identification of changes solely due to transfusion-induced acute lung injury. Research question: What are the unique blood signatures in indirect ARDS patients when transfusion factors are removed from the equation? |
| Patients without transfusion and with infectious pneumonia | – | Other: Blood sample collectionPurpose: Including this group clarifies the distinction between changes driven by infection and those unique to transfusion. By subtracting the effects of infectious responses, we can confirm that biomarkers are related specifically to TRALI. ABR 86798 CURIE study Version 5,April, 2025 16 of 35 Research question: How do the inflammatory cell and protein responses to localized lung infections compare to those induced by TRALI, ensuring biomarkers identified are specific to transfusion-related injury? |
| Healthy volunteers | – | Other: Blood sample collectionPurpose: The inclusion of healthy volunteers in this study is crucial. They provide a baseline of normal physiological and immunological steady-state composition of the blood, allowing us to identify biomarkers specific to TRALI and the other patient subgroups by accounting for baseline variability. This group serves as a valuable control for confounding factors such as critical illness (for which ICU admission), or pre-existing lung injury or concomitant systemic inflammation including the lung (ARDS), which might otherwise obscure the identification of TRALI-specific changes. This enhances data analysis and provides clarity in distinguishing potentially unique pathophysiologic mechanisms in TRALI. Research question: What baseline levels of protein, immune, and cellular profiles in healthy individuals differ from those in ICU patients undergoing transfusion, particular in terms of neutrophil activity, Treg function, and overall inflammation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Samples from twenty TRALI patients are already available at Sanquin Blood Bank. These samples have been collected within 24 hours after TRALI onset. The only clinical data available for these samples is sex and age. This is our study group. As control we will include ICU patients in University Medical Center (UMC): * Patients without lung injury receiving a blood transfusion; * Patients with indirect ARDS receiving a blood transfusion; * Patients with pneumonia receiving a blood transfusion; * Patients with indirect ARDS, who do not receive a blood transfusion; * Patients with pneumonia who do not receive a blood transfusion; * Healthy volunteers recruited through Sanquin's donor system
Key inclusion criteria (4 listed)
- Without lung injury who received a red blood cell (RBC) or platelet transfusion (PLT).
- With indirect ARDS with and without a blood transfusion (RBC or PLT);
- With pneumonia, with and without a blood transfusion (RBC or PLT).
Key exclusion criteria (4 listed)
- "Objection to registration of data for scientific use" as noted in the patient file.
- Patients in whom it is impossible to obtain blood samples.
- Patients with massive hemorrhage.
- Patients with ARDS due to multiple transfusions.
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 sample collectionAlso: Blood drawBlood samples of 30 mL will be collected at admission. For the groups that receive a blood transfusion an extra 30 mL blood sample will be collected. | Other | Healthy volunteers, ICU patients who receive a transfusion and have indirect ARDS, ICU patients who receive a transfusion and have infectious pneumonia, ICU patients who receive a transfusion without lung injury, ICU patients without transfusion and with indirect ARDS, Patients without transfusion and with infectious pneumonia |
Primary outcome
Biomarkers for TRALI
Time frame: From admission to the end of data collection (30 days)
The primary endpoint of this study is to identify TRALI-specific biomarkers by comparing plasma proteomic profiles between the following groups: TRALI patients, indirect ARDS patients (with and without transfusion), pneumonia patients (with and without transfusion), and healthy volunteers. To isolate the impact of transfusion on the proteome and differentiate it from TRALI-specific changes, we will also analyze proteomic profiles before and after transfusion in relevant groups. This approach aims to increase the specificity and sensitivity of identified protein biomarkers for accurate TRALI diagnosis and facilitate the development of novel diagnostic assays
2 secondary outcomes
Characterizing the TRALI proteome
Time frame: From admission to the end of data collection (30 days)
Investigating Neutrophil and Treg responses
Time frame: From admission to the end of data collection (30 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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.
Alexander Vlaar, Professor principal investigator
Amsterdam UMC
Questions about this trial
What is this clinical trial studying?
An observational study of Transfusion-Related Acute Lung Injury and ARDS, Human, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabella Viegen, Bsc (+31 20 566 3311, i.viegen@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers for TRALI (time frame: From admission to the end of data collection (30 days)). 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 4 Sep 2025.