GROUP FOR TRALI STUDY. SEMICYUC.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Hospitales Universitarios Virgen del Rocío
Hospital Universitario Reina Sofia
Germans Trias i Pujol Hospital
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Dr. Negrin University Hospital
Hospital Universitari Son Dureta
Hospital Miguel Servet
Information provided by:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier:
NCT01212640
First received: September 29, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.

Condition
Acute Lung Injury

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: GROUP FOR TRALI STUDY. SEMICYUC.

Resource links provided by NLM:


Further study details as provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:

Primary Outcome Measures:
  • Worsening of respiratory status [ Time Frame: October-November ] [ Designated as safety issue: Yes ]
    To research the worsening of respiratory status risk factors after transfusion in spanish critical care units.


Secondary Outcome Measures:
  • Incidence and morbi-mortality of TRALI [ Time Frame: October-November ] [ Designated as safety issue: Yes ]
    Determine the incidence and morbi-mortality of transfusion-related acute lung injury (TRALI) in critically ill patients.


Estimated Enrollment: 18
Study Start Date: October 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212640

Contacts
Contact: CARMEN MARIA FERRANDIZ, MD 955012528 carmenmferrandizm@hotmail.com

Locations
Spain
Hospital Virgen Del Rocio Not yet recruiting
Sevilla, Spain, 41013
Principal Investigator: CARMEN MARIA FERRANDIZ, MD         
Hospital Virgen Del Rocio Not yet recruiting
Seville, Spain, 41013
Principal Investigator: CARMEN MARIA FERRANDIZ, MD         
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Hospitales Universitarios Virgen del Rocío
Hospital Universitario Reina Sofia
Germans Trias i Pujol Hospital
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Dr. Negrin University Hospital
Hospital Universitari Son Dureta
Hospital Miguel Servet
Investigators
Principal Investigator: CARMEN MARIA FERRANDIZ, MD
  More Information

Publications:

Responsible Party: CARMEN MARIA FERRANDIZ MILLON, FISEVI
ClinicalTrials.gov Identifier: NCT01212640     History of Changes
Other Study ID Numbers: TRALI STUDY. SEMICYUC
Study First Received: September 29, 2010
Last Updated: September 29, 2010
Health Authority: Spain: Ethics Committee

Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Transfusion, distress

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Thoracic Injuries

ClinicalTrials.gov processed this record on July 29, 2014