NCT01212640

Brief Summary

OBJETIVES:

  1. 1.To research the worsening of respiratory status risk factors after transfusion in spanish critical care units.
  2. 2.To determine the incidence of transfusion-related acute lung injury (TRALI) in critically ill patients.
  3. 3.To research the morbi-mortality of TRALI.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 30, 2010

Status Verified

September 1, 2010

Enrollment Period

2 months

First QC Date

September 29, 2010

Last Update Submit

September 29, 2010

Conditions

Acute Lung Injury

Keywords

Transfusion, distress

Outcome Measures

Primary Outcomes (1)

  • Worsening of respiratory status

    To research the worsening of respiratory status risk factors after transfusion in spanish critical care units.

    October-November

Secondary Outcomes (1)

  • Incidence and morbi-mortality of TRALI

    October-November

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Virgen Del Rocio

Seville, Sevilla, 41013, Spain

Location

Hospital Virgen Del Rocio

Seville, Seville, 41013, Spain

Location

Related Publications (15)

  • 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.

    PMID: 19699017BACKGROUND

  • 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.

    PMID: 15818095BACKGROUND

  • 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. doi: 10.1016/j.tmrv.2004.10.001.

    PMID: 15830325BACKGROUND

  • 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. doi: 10.1164/rccm.200702-271OC. Epub 2007 Jul 12.

    PMID: 17626910BACKGROUND

  • 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. doi: 10.1097/01.ccm.0000165566.82925.14.

    PMID: 15942330BACKGROUND

  • 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.

    PMID: 19365816BACKGROUND

  • 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. doi: 10.1097/01.CCM.0000269037.66955.F0.

    PMID: 17507824BACKGROUND

  • 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.

    PMID: 19663827BACKGROUND

  • 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. doi: 10.1186/cc5934.

    PMID: 17553147BACKGROUND

  • 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.

    PMID: 19164959BACKGROUND

  • 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.

    PMID: 16361918BACKGROUND

  • 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.

    PMID: 20035217BACKGROUND

  • 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.

    PMID: 10390452BACKGROUND

  • 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.

    PMID: 18754313BACKGROUND

  • Rebibo D, Hauser L, Slimani A, Herve P, Andreu G. The French Haemovigilance System: organization and results for 2003. Transfus Apher Sci. 2004 Oct;31(2):145-53. doi: 10.1016/j.transci.2004.07.010.

    PMID: 15501418BACKGROUND

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • CARMEN MARIA FERRANDIZ, MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

CARMEN MARIA FERRANDIZ, MD

CONTACT

955012528carmenmferrandizm@hotmail.com

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2010

First Posted

September 30, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 30, 2010

Record last verified: 2010-09

Locations

ES(2)