Comparison of the Proteome in ICU Patients in Search for TRALI Biomarkers
- Conditions
- Transfusion-Related Acute Lung InjuryARDS, Human
- Interventions
- Other: Blood sample collection
- Registration Number
- NCT06444750
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 210
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ICU patients with pneumonia with transfusion Blood sample collection ICU patients who receive a transfusion and have infectious lung injury (locally). This will give an overview of the proteome of patients with local lung injury. ICU patients without lung injury with transfusion Blood sample collection ICU patients who receive a transfusion and without lung injury. This will give an overview of the proteome of critical ill patients who received a transfusion but without lung injury. This way specific proteome changes caused by transfusion can be identified ICU patients with ARDS (indirect) with transfusion Blood sample collection ICU patients who receive a transfusion and have ARDS caused by indirect lung injury (e.g. pancreatitis, trauma, non-pulmonary sepsis). This will give an overview of the proteome of critical ill patients who receive a transfusion and have lung injury not caused by TRALI. ICU patients with pneumonia without transfusion Blood sample collection ICU patients without transfusion and with infectious pneumonia. This will give an overview of proteins involved in local lung injury. Healthy volunteers Blood sample collection Healthy volunteers. ICU patients with ARDS (indirect) without transfusion Blood sample collection ICU patients without transfusion and with ARDS caused by indirect lung injury. This will give an overview of the proteome of ICU patients with a systemic cause of lung injury. Proteins that are specifically involved in a systemic reaction can be identified.
- Primary Outcome Measures
Name Time Method Biomarkers for TRALI Within 24 hours of ICU admission 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.
- Secondary Outcome Measures
Name Time Method CD34 cultured neutrophils Within 24 hours of ICU admission Measurement of CD34 cultured neutrophils. Neutrophil subsets will be checked for 20 markers in an antibody panel. This will be measured with flow cytometry.
T cell subsets within 24 hours of ICU admission Measurement of T cell subsets. This will be measured with flow cytometry.
Patient's proteome within 24 hours of ICU admission Effect of transfusion of patient's proteome in npx units