GROUP FOR TRALI STUDY. SEMICYUC.
Recruitment status was: Not yet recruiting
- To research the worsening of respiratory status risk factors after transfusion in spanish critical care units.
- To determine the incidence of transfusion-related acute lung injury (TRALI) in critically ill patients.
- To research the morbi-mortality of TRALI.
Acute Lung Injury
|Study Design:||Time Perspective: Prospective|
|Official Title:||GROUP FOR TRALI STUDY. SEMICYUC.|
- Worsening of respiratory status [ Time Frame: October-November ] [ Designated as safety issue: Yes ]To research the worsening of respiratory status risk factors after transfusion in spanish critical care units.
- Incidence and morbi-mortality of TRALI [ Time Frame: October-November ] [ Designated as safety issue: Yes ]Determine the incidence and morbi-mortality of transfusion-related acute lung injury (TRALI) in critically ill patients.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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).
Prospective multicenter observational study.
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212640
|Hospital Virgen Del Rocio|
|Sevilla, Spain, 41013|
|Hospital Virgen Del Rocio|
|Seville, Spain, 41013|
|Principal Investigator:||CARMEN MARIA FERRANDIZ, MD|