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GROUP FOR TRALI STUDY. SEMICYUC.

GROUP FOR TRALI STUDY. SEMICYUC.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01212640
Enrollment
18
Registered
2010-09-30
Start date
2010-10-31
Completion date
2010-12-31
Last updated
2010-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lung Injury

Keywords

Transfusion, distress

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.

Interventions

None listed

Sponsors

Hospitales Universitarios Virgen del Rocío
CollaboratorOTHER
Hospital Universitario Reina Sofia de Cordoba
CollaboratorOTHER_GOV
Germans Trias i Pujol Hospital
CollaboratorOTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
CollaboratorOTHER
Dr. Negrin University Hospital
CollaboratorOTHER
Hospital Universitari Son Dureta
CollaboratorOTHER
Hospital Miguel Servet
CollaboratorOTHER
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Worsening of respiratory statusOctober-NovemberTo research the worsening of respiratory status risk factors after transfusion in spanish critical care units.

Secondary

MeasureTime frameDescription
Incidence and morbi-mortality of TRALIOctober-NovemberDetermine the incidence and morbi-mortality of transfusion-related acute lung injury (TRALI) in critically ill patients.

Countries

Spain

Contacts

Primary ContactCARMEN MARIA FERRANDIZ, MD
carmenmferrandizm@hotmail.com955012528

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026