Clinical trial NCT06444750: Comparison of the Proteome in ICU Patients in Search for TRALI Biomarkers
Official title: Comparison of the Proteome in ICU Patients in Search for TRALI Biomarkers: A Case-control Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Transfusion-Related Acute Lung Injury
ARDS, Human
Keywords: Transfusion-Related Acute Lung Injury
Proteomics
Intensive Care Unit
Critical Ill patients
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ARDS patients, pneumonia patients, patients without lung injury admitted to the adult intensive care who do or do not receive a blood transfusion, and healthy volunteers.

Brief 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. The incidence of TRALI is 50-100 times higher in critically ill patients compared to the general hospital population. No biomarkers are yet known to detect TRALI. This study will compare blood samples of TRALI patients with blood samples of intensive care patients in order to find possible biomarkers for TRALI.

Detailed description: Background of the 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. 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 pathophysiology of TRALI. Consequently, no biomarkers are yet known to detect TRALI. This study aims to gain insight in cellular pathways underlying TRALI development which could enhance transfusion safety.

Objective of the study:

* 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 identify biomarkers specific for TRALI, thus aiding in future diagnostics of TRALI.

Study design:

Case-control study. 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) or pneumonia.

The investigator will screen ICU patients for eligibility for one of our groups and ask for informed consent. After obtaining informed consent, patients depending on whether they need a transfusion. After admission and informed consent the investigator will collect remaining blood samples from the clinical laboratory within 24 hours of arrival.

Additionally, extra blood samples (40mL) 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 ARDS), and Group 3 (patients who receive a transfusion with local lung injury) a second tube blood sample (30mL) will be drawn 12 hours after the first transfusion. The investigator will collect two samples for this group to analyze the effect of transfusion on the proteome

Study population:

Adult intensive care patient who are admitted with:

- pneumonia, indirect lung injury or no pulmonary injury Healthy volunteers.

Primary study parameters/outcome of the study:

The main aim of this research is to use proteomics to study protein profiles and identify biomarkers that correlate with TRALI.

Secundary study parameters/outcome of the study (if applicable):

The secondary outcomes of this research will be CD34 cultured neutrophils and T cell subsets. Furthermore, the effect of transfusion on the patient's proteome will be studied.

Eligibility criteria: Inclusion Criteria:

Patients on the ICU:

* Without lung injury who received a red blood cell or platelet transfusion.
* Non-lung infection induced ARDS with and without a blood transfusion;
* Pneumonia, without a blood transfusion.

Exclusion Criteria:

* Patients with "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 haemorrhage.

Primary outcomes:
measure: Biomarkers for TRALI
timeFrame: Within 24 hours of ICU admission
Secondary outcomes:
measure: CD34 cultured neutrophils
timeFrame: Within 24 hours of ICU admission
measure: T cell subsets
timeFrame: within 24 hours of ICU admission
measure: Patient's proteome
timeFrame: within 24 hours of ICU admission
Other outcomes:
Locations:
Study officials:
affiliation: Amsterdam UMC
name: Alexander Vlaar, Professor
role: PRINCIPAL_INVESTIGATOR
References: