- 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…
ID
Source
Brief title
Condition
- Haematological disorders NEC
Synonym
Health condition
transfusie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
The secundary outcomes of this study are:
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.
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.
Background 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. 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.
Study objective
- 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 burden and risks
This is a case-control study using prospective and retrospective samples with
limited patient burden. We will collect routine clinical data and a maximum of
two blood samples. This study does not result in any risk, interventions or
burdens to patients and/or family.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Adult ICU patients:
- ICU patients who receive a transfusion without lung injury
- ICU patients who receive a transfusion and have indirect ARDS (e.g. due to
pancreatitis, trauma, etc),
- ICU patients who receive a transfusion and have infectious pneumonia
- ICU patients without transfusion and with non-pulmonary indirect ARDS
- ICU patients without transfusion and with infectious pneumonia
- Healthy volunteers recruited through Sanquin*s donor system
Exclusion criteria
Patients with objection to registration of data for scientific use as noted in
the patient file
Patient in whom it is impossible to obtain blood samples
Patients with massive haemorrhage
Patients with ARDS due to multiple transfusions
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86798.018.24 |