The Incidence of TRALI in Patients Undergoing Orthopedic-Oncology Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00914784
First received: June 4, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: June 4, 2009
Last Updated: June 4, 2009
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 18, 2014