GROUP FOR TRALI STUDY. SEMICYUC.

Acute Lung Injury Clinical Trial

Official title:

GROUP FOR TRALI STUDY. SEMICYUC.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01212640
• Other study ID #: TRALI STUDY. SEMICYUC
• Status: Not yet recruiting
• Phase: N/A
• First received: September 29, 2010
• Last updated: September 29, 2010
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: September 2010
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: CARMEN MARIA FERRANDIZ, MD
• Phone: 955012528
• Email: carmenmferrandizm[@]hotmail.com
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Respiratory Distress Syndrome, Adult

Locations

Country	Name	City	State
Spain	Hospital Virgen Del Rocio	Sevilla
Spain	Hospital Virgen Del Rocio	Seville

Sponsors (8)

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

Country where clinical trial is conducted

Spain, 

References & Publications (15)

Benson AB, Moss M, Silliman CC. Transfusion-related acute lung injury (TRALI): a clinical review with emphasis on the critically ill. Br J Haematol. 2009 Nov;147(4):431-43. doi: 10.1111/j.1365-2141.2009.07840.x. Epub 2009 Aug 5. Review. — View Citation

Chaiwat O, Lang JD, Vavilala MS, Wang J, MacKenzie EJ, Jurkovich GJ, Rivara FP. Early packed red blood cell transfusion and acute respiratory distress syndrome after trauma. Anesthesiology. 2009 Feb;110(2):351-60. doi: 10.1097/ALN.0b013e3181948a97. — View Citation

Eder AF, Benjamin RJ. TRALI risk reduction: donor and component management strategies. J Clin Apher. 2009;24(3):122-9. doi: 10.1002/jca.20198. Review. — View Citation

Gajic O, Rana R, Winters JL, Yilmaz M, Mendez JL, Rickman OB, O'Byrne MM, Evenson LK, Malinchoc M, DeGoey SR, Afessa B, Hubmayr RD, Moore SB. Transfusion-related acute lung injury in the critically ill: prospective nested case-control study. Am J Respir Crit Care Med. 2007 Nov 1;176(9):886-91. Epub 2007 Jul 12. — View Citation

Goldman M, Webert KE, Arnold DM, Freedman J, Hannon J, Blajchman MA; TRALI Consensus Panel. Proceedings of a consensus conference: towards an understanding of TRALI. Transfus Med Rev. 2005 Jan;19(1):2-31. — View Citation

Gong MN, Thompson BT, Williams P, Pothier L, Boyce PD, Christiani DC. Clinical predictors of and mortality in acute respiratory distress syndrome: potential role of red cell transfusion. Crit Care Med. 2005 Jun;33(6):1191-8. — View Citation

Rebibo D, Hauser L, Slimani A, Hervé P, Andreu G. The French Haemovigilance System: organization and results for 2003. Transfus Apher Sci. 2004 Oct;31(2):145-53. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Wiersum-Osselton JC, Porcelijn L, van Stein D, Vlaar AP, Beckers EA, Schipperus MR. [Transfusion-related acute lung injury (TRALI) in the Netherlands in 2002-2005]. Ned Tijdschr Geneeskd. 2008 Aug 9;152(32):1784-8. Dutch. — View 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. — View Citation

Yilmaz M, Keegan MT, Iscimen R, Afessa B, Buck CF, Hubmayr RD, Gajic O. Toward the prevention of acute lung injury: protocol-guided limitation of large tidal volume ventilation and inappropriate transfusion. Crit Care Med. 2007 Jul;35(7):1660-6; quiz 1667. — View Citation

Zilberberg MD, Carter C, Lefebvre P, Raut M, Vekeman F, Duh MS, Shorr AF. Red blood cell transfusions and the risk of acute respiratory distress syndrome among the critically ill: a cohort study. Crit Care. 2007;11(3):R63. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Worsening of respiratory status	To research the worsening of respiratory status risk factors after transfusion in spanish critical care units.	October-November	Yes
Secondary	Incidence and morbi-mortality of TRALI	Determine the incidence and morbi-mortality of transfusion-related acute lung injury (TRALI) in critically ill patients.	October-November	Yes