Comparison of the Proteome in ICU Patients in Search for TRALI Biomarkers

ARDS, Human Clinical Trial

— CURIE  

Official title:

Comparison of the Proteome in ICU Patients in Search for TRALI Biomarkers: A Case-control Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444750
• Other study ID #: CURIE
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Isabella Viegen, Bsc
• Phone: +31 20 566 3311
• Email: i.viegen[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS, Human
• Lung Injury
• Respiratory Distress Syndrome
• Transfusion-Related Acute Lung Injury

Intervention

Other:
• Blood sample collection
Blood sample collection of maximum 70 ml

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers for TRALI	Use proteomics (OLINK) to study protein profiles and identify biomarkers. This will be measured in Normalized Protein eXpression (NPX) units biomarkers that correlate with TRALI.	Within 24 hours of ICU admission
Secondary	CD34 cultured neutrophils	Measurement of CD34 cultured neutrophils. Neutrophil subsets will be checked for 20 markers in an antibody panel. This will be measured with flow cytometry.	Within 24 hours of ICU admission
Secondary	T cell subsets	Measurement of T cell subsets. This will be measured with flow cytometry.	within 24 hours of ICU admission
Secondary	Patient's proteome	Effect of transfusion of patient's proteome in npx units	within 24 hours of ICU admission