Acute Lung Injury Clinical Trial
Official title:
GROUP FOR TRALI STUDY. SEMICYUC.
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.
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. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Virgen Del Rocio | Sevilla | |
Spain | Hospital Virgen Del Rocio | Seville |
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 |
Spain,
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
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 |
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