Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444750
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-31
Brief Title:
Comparison of the Proteome in ICU Patients in Search for TRALI Biomarkers
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Comparison of the Proteome in ICU Patients in Search for TRALI Biomarkers A Case-control Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CURIE
Brief Summary:
Transfusion-related acute lung injury TRALI is a severe complication of blood transfusions After a transfusion TRALI develops in 008-15 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 008-15 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 parametersoutcome 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 parametersoutcome 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 patients proteome will be studied
Transfusion-related acute lung injury TRALI is a severe complication of blood transfusions After a transfusion TRALI develops in 008-15 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 parametersoutcome 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 parametersoutcome 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 patients proteome will be studied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None