GROUP FOR TRALI STUDY. SEMICYUC.

• Conditions: Acute Lung Injury

• Registration Number: NCT01212640
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2010-09
• Study First Submitted: 2010-09-29
• Study First Submitted QC: 2010-09-29
• Last Update Submitted: 2010-09-29
• Study First Posted: 2010-09-30
• Last Update Posted: 2010-09-30
• Study Start: 2010-10
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• All patients transfused in eleven spanish intensive care units (UCI) from October 1, until November 30, 2010.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Worsening of respiratory status	October-November	To research the worsening of respiratory status risk factors after transfusion in spanish critical care units.

Secondary Outcome Measures

Name	Time	Method
Incidence and morbi-mortality of TRALI	October-November	Determine the incidence and morbi-mortality of transfusion-related acute lung injury (TRALI) in critically ill patients.

Trial Locations

Locations (1)

Hospital Virgen Del Rocio; 🇪🇸 Seville, Spain