Fondazione Policlinico Gemelli IRCCS
Roma, 00168, Italy
Location status: Recruiting
NCT Number: NCT06443515
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.
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All sexes
Interventional
Not applicable
Roma, 00168, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: within 6 hours before and after the transfusion
LUS score according to previous publications (Brat et al., 2015) will be calculated
Time frame: within 6 hours before and after the transfusion
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
MAP as displayed by ventilators will be recorded as median values
Contact information is provided by the study sponsor or research team.
Stefano Nobile
CONTACT
Stefano Nobile, MD, PhD, MSc
CONTACT
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Evaluation of Respiratory Trends During Blood Transfusions in Newborns.
Acronym: ARTE
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