Clinical trial NCT01212640: GROUP FOR TRALI STUDY. SEMICYUC.
Official title: GROUP FOR TRALI STUDY. SEMICYUC.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lung Injury
Keywords: Transfusion, distress
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
Collaborators: name: Hospitales Universitarios Virgen del Rocío
name: Hospital Universitario Reina Sofia de Cordoba
name: Germans Trias i Pujol Hospital
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Dr. Negrin University Hospital
name: Hospital Universitari Son Dureta
name: Hospital Miguel Servet
First posted: 2010-09-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Worsening of respiratory status
timeFrame: October-November
Secondary outcomes:
measure: Incidence and morbi-mortality of TRALI
timeFrame: October-November
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Virgen Del Rocio
city: Seville
country: Spain
facility: Hospital Virgen Del Rocio
Study officials:
name: CARMEN MARIA FERRANDIZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silliman CC, Fung YL, Ball JB, Khan SY. Transfusion-related acute lung injury (TRALI): current concepts and misconceptions. Blood Rev. 2009 Nov;23(6):245-55. doi: 10.1016/j.blre.2009.07.005. Epub 2009 Aug 20.
citation: Toy P, Popovsky MA, Abraham E, Ambruso DR, Holness LG, Kopko PM, McFarland JG, Nathens AB, Silliman CC, Stroncek D; National Heart, Lung and Blood Institute Working Group on TRALI. Transfusion-related acute lung injury: definition and review. Crit Care Med. 2005 Apr;33(4):721-6. doi: 10.1097/01.ccm.0000159849.94750.51.
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citation: Silverboard H, Aisiku I, Martin GS, Adams M, Rozycki G, Moss M. The role of acute blood transfusion in the development of acute respiratory distress syndrome in patients with severe trauma. J Trauma. 2005 Sep;59(3):717-23.
citation: Vlaar AP, Binnekade JM, Prins D, van Stein D, Hofstra JJ, Schultz MJ, Juffermans NP. Risk factors and outcome of transfusion-related acute lung injury in the critically ill: a nested case-control study. Crit Care Med. 2010 Mar;38(3):771-8. doi: 10.1097/CCM.0b013e3181cc4d4b.
citation: Williamson LM, Lowe S, Love EM, Cohen H, Soldan K, McClelland DB, Skacel P, Barbara JA. Serious hazards of transfusion (SHOT) initiative: analysis of the first two annual reports. BMJ. 1999 Jul 3;319(7201):16-9. doi: 10.1136/bmj.319.7201.16.
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