Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443515
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Brief Title:
Respiratory Trends During Blood Transfusions in Newborns
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Evaluation of Respiratory Trends During Blood Transfusions in Newborns
Status:
RECRUITING
Status Verified Date:
2024-09
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:
ARTE
Brief 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
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
Detailed Description:
None
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