Trials / Recruiting
RecruitingNCT06443515
Respiratory Trends During Blood Transfusions in Newborns.
Evaluation of Respiratory Trends During Blood Transfusions in Newborns.
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 71 (estimated)
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
- Sex
- All
- Age
- 1 Month
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Blood Transfusion Complication
- Blood Transfusion Associated Adverse Reactions
- Respiratory Complication
- Respiratory Morbidity
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-07-01
- Primary completion
- 2025-12-31
- Completion
- 2026-01-15
- First posted
- 2024-06-05
- Last updated
- 2024-09-24
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT06443515. Inclusion in this directory is not an endorsement.