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Acute Lung InjuryNCT01212640

GROUP FOR TRALI STUDY. SEMICYUC.

An observational study of Acute Lung Injury, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 2 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Lung Injury
How many people
18 participants
Where
2 sitesSpain
Study dates
Oct 2010to Dec 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

CARMEN MARIA FERRANDIZ, MD contact

955012528

carmenmferrandizm@hotmail.com

Spain2 sites

  • Hospital Virgen Del Rocio

    Seville, Sevilla, 41013

    CARMEN MARIA FERRANDIZ, MD

  • Hospital Virgen Del Rocio

    Seville, Seville, 41013

    CARMEN MARIA FERRANDIZ, MD

Other trials in Spain

About this study

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.
Read the 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.

Keywords
Transfusion, distress
Medical subject headings
Acute Lung Injury

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Worsening of respiratory status

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

    Measured: October-November

Secondary outcomes (1)

  1. Incidence and morbi-mortality of TRALI

    Determine the incidence and morbi-mortality of transfusion-related acute lung injury (TRALI) in critically ill patients.

    Measured: October-November

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionDec 2010 (estimated)
  4. Study completionDec 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01212640
Sponsor's protocol ID
TRALI STUDY. SEMICYUC
Status last verified
Sep 2010
First submitted
29 Sep 2010
Last updated
30 Sep 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19699017

  • 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.

    PubMed 15818095

  • 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.

    PubMed 15830325

  • 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.

    PubMed 17626910

  • 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.

    PubMed 15942330

  • 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.

    PubMed 19365816

  • 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.

    PubMed 17507824

  • 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.

    PubMed 19663827

  • 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.

    PubMed 17553147

  • 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.

    PubMed 19164959

  • 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.

    PubMed 16361918

  • 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.

    PubMed 20035217

  • 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.

    PubMed 10390452

  • 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.

    PubMed 18754313

  • 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.

    PubMed 15501418

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Lung Injury, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact CARMEN MARIA FERRANDIZ, MD (955012528, carmenmferrandizm@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Worsening of respiratory status (time frame: October-November). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01212640, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2010.

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