Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer

PHASE3TerminatedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

December 31, 2005

Study Completion Date

March 31, 2007

Conditions
Blood Loss, Surgical
Interventions
DRUG

Trasylol (Aprotinin, BAYA0128)

"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"

DRUG

Placebo

Placebo solution was supplied in identical vials and will consist of 200mL of 0.9% sodium chloride.

Trial Locations (21)

22908

Charlottesville

27710

Durham

30322

Atlanta

30912

Augusta

46202

Indianapolis

46260

Indianapolis

77030

Houston

84108

Salt Lake City

02115-6195

Boston

63110-1094

St Louis

44106-2602

Cleveland

15213-2592

Pittsburgh

Unknown

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Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT00306137 - Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer | Biotech Hunter | Biotech Hunter