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The Incidence of TRALI in Patients Undergoing Orthopedic-Oncology Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00914784
First Posted: June 5, 2009
Last Update Posted: June 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tel-Aviv Sourasky Medical Center
  Purpose
Currently Transfusion-related acute lung injury (TRALI) is the leading cause of transfusion-related mortality in the United States, and one of major post-transfusion complications. TRALI is defined as new ALI occurring within 6 hours from the onset of transfusion. It is manifested by acute dyspnea, hypoxemia and bilateral infiltrates in chest radiograph. TRALI may be caused by any blood product and is not dose-dependent. Associated risk factors include prolonged storage of blood products and underlying conditions such as severe IHD hematologic malignancies or active infections. Since TRALI has only recently been defined as a clinical entity, and its prevalence has been largely underestimated - the epidemiology of TRALI is not well established. Therefore the objective of this work is to study the incidence of TRALI in a patient population that receive blood products frequently, namely orthopedic-oncologic.

Condition
Dyspnea Pulmonary Edema

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Incidence of Transfusion-Related Acute Lung Injury (TRALI) Following Blood Product Transfusion in Patients Undergoing Elective Orthopedic-Oncology Procedures

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • The incidence of TRALI in patients undergoing orthopedic-oncology procedures, following blood product transfusion [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • The correlation between the incidence of TRALI and the age of blood product [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
blood from arterial line to test for PaO2

Estimated Enrollment: 550
Study Start Date: August 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients aged >18 years old, with ASA I-III, undergoing elective orthopedic-oncology procedures in the Sourasky Medical Center, and receiving blood products pre-, intra-, or post-operatively.
Criteria

Inclusion Criteria:

  • Patients aged >18 years old, with ASA I-III, undergoing elective orthopedic-oncology procedures in the Sourasky Medical Center, and receiving blood products pre-, intra-, or post-operatively.

Exclusion Criteria:

  • Patients with a history of chronic renal insufficiency (creatinine > 1.5 of normal value), congestive heart failure, hepatic dysfunction, preexisting ALI, or acute infection.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914784


Contacts
Contact: Idit Matot, MD 97236974758 iditm@tasmc.health.gov.il
Contact: Yifat Klein, PhD 97236974093 yifat.klein@gmail.com

Locations
Israel
Tel Aviv Sourasky medical center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Yifat Klein, PhD    9726974093    yifat.klein@gmail.com   
Sub-Investigator: Shlomo Dadia, MD         
Sub-Investigator: Alex Gorodetsky, MD         
Sub-Investigator: Yifat Klein, PhD         
Principal Investigator: Idit Matot, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Study Chair: Idit Matot, MD Tel-Aviv Sourasky Medical Center
  More Information

Responsible Party: Prof Idit Matot, Department of anesthesia and intensive care, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00914784     History of Changes
Other Study ID Numbers: TASMC-09-IM-0295-CTIL
First Submitted: June 4, 2009
First Posted: June 5, 2009
Last Update Posted: June 5, 2009
Last Verified: June 2009

Keywords provided by Tel-Aviv Sourasky Medical Center:
TRALI
Transfusion
dyspnea
pulmonary infiltrates

Additional relevant MeSH terms:
Dyspnea
Pulmonary Edema
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Diseases