Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
Subjects successfully meeting all screening criteria will be randomized to receive an infusion of aprotinin (a test dose followed by a loading dose of 2 million KIU before skin incision followed by 500,000 KIU/hour until the end of surgery) or matching placebo. The aprotinin was supplied in infusion vials of 200mL solution containing 2,000,000 KIU (10,000 KIU/mL) in 0.9% sodium chloride. Subjects will be stratified into one of the 4 following strata: * Stratum 1: complete primary pneumonectomy * Stratum II: decortication or completion pneumonectomy * Stratum III: esophagectomy by transhiatal approach * Stratum IV: esophagectomy by transthoracic approach
Placebo solution was supplied in identical vials and will consist of 200mL of 0.9% sodium chloride.
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Augusta, Georgia, United States
Unnamed facility
Indianapolis, Indiana, United States
Percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period
Time frame: Up to the end of follow up visit (4 to 8 weeks)
Number of units of blood or packed red cells transfused
Time frame: Up to the end of follow up visit (4 to 8 weeks)
Number of units transfused per patient
Time frame: Up to the end of follow up visit (4 to 8 weeks)
Intra-operative blood loss
Time frame: Intra-operative
Drainage volume
Time frame: Until removal of drains
Transfusion of platelets, colloids and plasma
Time frame: Up to the end of follow up visit (4 to 8 weeks)
Change from pre-operative to post-operative hemoglobin concentration
Time frame: At day 3 or earlyer prior to transfusion
Surgeon's assessment of obscurement of operative field by bleeding
Time frame: Up to the end of follow up visit (4 to 8 weeks)
Blood markers of inflammation and coagulation
Time frame: Up to the end of follow up visit (4 to 8 weeks)
Time to discontinuation of mechanical ventilation
Time frame: Until removal of mechanical ventilation
Health related quality of life measurements
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Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Durham, North Carolina, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Pittsburgh, Pennsylvania, United States
Unnamed facility
Houston, Texas, United States
...and 11 more locations
Time frame: Up to the end of follow up visit (4 to 8 weeks)