Status:
COMPLETED
Mild Pulmonary Function Changes With Transfusion
Lead Sponsor:
University of California, San Francisco
Conditions:
Transfusion Reactions
Eligibility:
All Genders
16-75 years
Brief Summary
The purpose of the study is to determine whether transfusion is associated with mild pulmonary changes.
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- Patients who are undergoing substantial posterior spinal reconstruction are chosen as the study population because (1) the need for transfusion is highly predictable; (2) all have endotracheal tubes to allow for controlled ventilation and control of inspired gases; (3) the availability of stored non-leukoreduced autologous packed red blood cells (prbcs) will enable comparison of effects of autologous blood containing elevated concentrations of pro-inflammatory cytokines and lyso-phosphatidyl choline with that of autologous red cells without elevated concentrations of pro-inflammatory cytokines (salvaged cells); (4) all have arterial catheters allowing for frequent sampling of arterial blood for blood gas determinations; (5) all have central venous catheters to guide fluid therapy and ensure the absence of fluid overload, thus eliminating an important confounder in assessing alterations of lung function after transfusion. For those not having autologous blood, it will be possible to compare the effects of blood containing elevated concentrations of pro-inflammatory cytokines and lyso-phosphatidyl choline normally associated with blood storage with that of autologous red cells without elevated concentrations of pro-inflammatory cytokines (salvaged cells).
- Patients, male or female, any race or ethnicity, age 16-75 years, undergoing elective posterior spine surgery at University of California, San Francisco (UCSF) with expected sufficient blood loss to require intra-operative cell salvage and blood transfusion, who have donated blood for themselves preoperatively. -
Exclusion
- Patients are excluded who are under 16 or over 75 year of age. Also excluded are those that have pulmonary disease, abnormal pulmonary function or gas exchange by history or physical examination, and pre-operative measurement of oxyhemoglobin saturation (percutaneous); any operative procedure within one week of study; active infection; cardiac failure.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00681954
Start Date
October 1 2005
End Date
January 1 2014
Last Update
January 16 2015
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94143