An interventional study of lung ultrasound in Blood Transfusion Complication, Blood Transfusion Associated Adverse Reactions and Respiratory Complication, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged Up to 1 Month. Per ClinicalTrials.gov, last updated 2024-09-24.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Diagnostic
The prevalence of transfusion reactions is between 1 and 11% of transfusions. Most reactions are mild and do not pose a life-threatening risk to the patient. More serious problems may be the only manifestations that lead to suspicion of a transfusion reaction.
Most noninfectious transfusion reactions are immune-mediated. Two main types of reactions can be distinguished: TACO (transfusion associated cardiac overload, which is a cardiogenic pulmonary edema) and TRALI (transfusion related acute lung injury, non-cardiogenic pulmonary edema).
Although TRALI are diagnoses of exclusion, the presence of noncardiogenic pulmonary edema and respiratory problems in the vicinity of blood product transfusions should raise suspicion. Other signs of TRALI are hypotension and tachycardia, while in TACO arterial hypertension with positive water balance can be observed.
According to previous reports, the prevalence of transfusion reactions in the neonatal population is approximately 8%. Factors associated with these reactions are low birth weight and low gestational age. However, diagnostic criteria of respiratory transfusion reactions are not uniform across studies, and often the generic terms "acute lung injury" have been used.
Therefore, the primary objective of this study is to evaluate the respiratory trend during blood transfusions; secondary objectives are the study of risk factors for the development of respiratory worsening and the possible association with complications.
56 studies on the registry are indexed under Transfusion Reaction; 12 are open to participants now.
This study's planned enrollment of 71 is close to the median of 71 across 23 interventional studies indexed under Transfusion Reaction.
Browse Transfusion Reaction studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All infants undergoing blood transfusions will be enrolled in the study
Diagnostic Test: lung ultrasound
Lung ultrasound examinations will be performed within 6 hours before and after blood transfusion to assess interstitial-alveolar fluid retention and calculate a LUS score
Changes in lung ultrasound score (LUS score) before and after transfusions
LUS score according to previous publications (Brat et al., 2015) will be calculated
Time frame: within 6 hours before and after the transfusion
Changes in non-invasive peripheral oxygen saturation/fraction of inspired oxygen (SFR) before and after transfusions
non-invasive peripheral oxygen saturation/fraction of inspired oxygen (SFR) will be calculated from clinical charts: data validated by caregivers (primary nurses) will be extracted from the electronic charts to calculate this ratio
Time frame: within 6 hours before and after the transfusion
Changes in ventilatory parameters (mean airway pressure) for patients on nasal continuous positive airway pressure (nCPAP) or mechanical ventilation
MAP as displayed by ventilators will be recorded as median values
Time frame: within 6 hours before and after the transfusion
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Dec 2025, 17 months after the start.
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