Acute Lung Injury Clinical Trial
Official title:
GROUP FOR TRALI STUDY. SEMICYUC.
OBJETIVES:
1. To research the worsening of respiratory status risk factors after transfusion in
spanish critical care units.
2. To determine the incidence of transfusion-related acute lung injury (TRALI) in
critically ill patients.
3. To research the morbi-mortality of TRALI.
Actually there are no published European data on the incidence of acute lung injury by
transfusion (TRALI) in critically ill patients, in Europe, estimates of TRALI incidence are
limited to passive reports of national blood banks. This multicenter study of Spanish ICUs
will investigate the incidence and TRALI predisposing factors (associated with the patient,
the transfused blood product and the presence or absence of mechanical ventilation).
Design:
Prospective multicenter observational study.
Patients:
All patients transfused in eleven spanish intensive care units (UCI) from October 1, until
November 30, 2010. Patients with less of 18 years old, or transfused six hours before be
included in this study or seriousness patients with a length of stay <24 hrs will be
excluded.
Variables:
- Patient data collection: Demografic data (age, gender), Clinical data (comorbid
conditions), Admission diagnostic , Complications during the stay and severity of
illness scores: Acute Physiology and Chronic Health Evaluation (APACHE II) score,
Sequential Organ Failure Assessment (SOFA) score, Euroscore.
- Transfusion factors: Type of blood product, time of infusion and volumen transfused,
storage age and donor sex.
- Respiratory factors: Main ventilation and oxigenation parameters and type of
respiratory support before and after transfusion.
For each transfusion episode was completed two data tables (see last page of the booklet of
data collection):
- Before the transfusion (baseline) are listed the values of the patient's respiratory
function, the analytical value that is transfused (Hb, INR, APTT, PT, platelets) and
the number of the bag that is transfused (to apply blood bank storage time and sex of
the donor).
- After the transfusion are recorded the volume and time infusion and 6 hours after
transfusion are collected again the parameters of the patient's respiratory function
and radiographic changes.
According to official criteria shall be noted if the patient has exhibited a classic TRALI,
possible TRALI, or a worsening of their respiratory function after transfusion.
;
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