Mild Pulmonary Function Changes With Transfusion
The purpose of the study is to determine whether transfusion is associated with mild pulmonary changes.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Mild Pulmonary Function Changes With Transfusion|
- Lung compliance and dead space. [ Time Frame: Before and after transfusion ] [ Designated as safety issue: No ]
- White blood cell count before and after transfusion [ Time Frame: Before and after transfusion ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Biospecimens are retained for cytokine and inflammatory marker analyses.
|Study Start Date:||October 2005|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
|1, 2, 3|
Transfusion-related acute lung injury (TRALI) is the leading cause of blood product related death. The precise mechanisms of TRALI are uncertain. We hypothesize that TRALI is a full spectrum of lung injury. One theory holds that the infusion of cytokines associated with the transfusion of stored blood combined with the trauma and stress of surgery produce lung injury. We propose to examine lung function following transfusion, and that stored blood (and by implication, cytokines) injures the lung. TRALI is a rare condition and we do not expect any of the patients that we observe will develop TRALI. We are merely observing their pulmonary function closely to see if there are any mild changes.
Patients will be randomized into three groups based on whether or not they have pre-donated blood for the surgery. Once divided into these groups they are randomized to one of three groups with patients in the first group randomized to receive their stored (either autologous or allogeneic) "unwashed" blood first in the operating room using the standard cell salvage system. The second group will receive their stored (either autologous or allogeneic) "washed" blood first and the third group will receive blood from the cell salvage system first. Those who get the stored blood first will get the cell salvage blood as their second transfusion and those that get the cell salvage blood first will get stored "unwashed" blood as the second transfusion in the operating room. We will closely monitor pulmonary function and oxygenation, and try to observe whether there is early evidence of lung changes. If there is evidence of lung changes, then the blood is tested for cytokines and antibodies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681954
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94143|
|Study Director:||Michael Gropper, MD||University of California, San Francisco|