Comparison of the Proteome in ICU Patients in Search for TRALI Biomarkers: A Case-control Study Using Both Retrospective and Prospective Samples

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

"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 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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Blood sample collection

    Other intervention

    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.

Treatment groups

210 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: ICU patients who receive a transfusion without lung injury1 intervention
Group B: ICU patients who receive a transfusion and have indirect ARDS1 intervention
Group C: ICU patients who receive a transfusion and have infectious pneumonia1 intervention
Group D: ICU patients without transfusion and with indirect ARDS1 intervention
Group E: Patients without transfusion and with infectious pneumonia1 intervention
Group F: Healthy volunteers1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From admission to the end of data collection (30 days)

Secondary outcomes

1

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.

Time frame
From admission to the end of data collection (30 days)
2

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.

Time frame
From admission to the end of data collection (30 days)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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