Respiratory Trends During Blood Transfusions in Newborns.
Recruiting now · Not applicable
Conditions studied: Blood Transfusion Complication, Blood Transfusion Associated Adverse Reactions, Respiratory Complication, Respiratory Morbidity
In brief
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.
Key facts
- Study ID
- NCT06443515
- Run by
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- People needed
- 71
- Starts
- 2024-07-01
- Expected to finish
- 2026-01-15
- Last updated by the study team
- 2024-09-24
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- admitted newborns requiring blood transfusions as per local practice and/or international guidelines
You may not qualify if…
- newborns with major malformations
- need for palliative care
- lack of informed consent
Where it is running
- Fondazione Policlinico Gemelli IRCCS — Roma, Italy (enrolling)
Full record on ClinicalTrials.gov
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