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

Phase 3

Terminated

• Conditions: Blood Loss, Surgical
• Interventions: Drug: Placebo; Drug: Trasylol (Aprotinin, BAYA0128)

• Registration Number: NCT00306137
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-03-21
• Study First Submitted QC: 2006-03-21
• Study First Posted: 2006-03-23
• Study Completion: 2007-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Men or women 18 years of age and older
• Subjects requiring protocol specified oncological surgery. Subjects must have histological confirmation of malignancy in lung or esophagus
• Documented, signed and dated informed consent obtained prior to any study specific procedures being performed

Exclusion Criteria

• Subjects with previous exposure to aprotinin in the last 6 months or with a known or suspected allergy to aprotinin
• Subjects undergoing laparoscopic surgery
• Subjects with sepsis or mesothelioma
• Subjects with impaired renal function (serum creatinine >2.5 mg/dL or 221 micromoles/liter)
• Subjects with a history of bleeding diathesis, deep vein thrombosis or pulmonary embolism or known coagulation factor deficiency. Based on the investigator's opinion of any active significant medical illness the subject may have.
• Subjects who refuse to receive allogenic blood products or whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit of <24% or hemoglobin of <8 g/dl)
• Subjects who have participated in an investigational drug study within the past 30 days
• Subjects who are pregnant or breastfeeding or women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative pregnancy test and who are not using a reliable method of contraception
• Planned use of other antifibrinolytic agents, e.g. aminocaproic acid or tranexamic acid
• Subjects on chronic anticoagulant treatment with warfarin that cannot be temporarily discontinued for the surgical procedure (as per local practices)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Placebo	-
Arm 1	Trasylol (Aprotinin, BAYA0128)	-

Primary Outcome Measures

Name	Time	Method
Percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period	Up to the end of follow up visit (4 to 8 weeks)

Secondary Outcome Measures

Name	Time	Method
Blood markers of inflammation and coagulation	Up to the end of follow up visit (4 to 8 weeks)
Time to discontinuation of mechanical ventilation	Until removal of mechanical ventilation
Health related quality of life measurements	Up to the end of follow up visit (4 to 8 weeks)
Intra-operative blood loss	Intra-operative
Transfusion of platelets, colloids and plasma	Up to the end of follow up visit (4 to 8 weeks)
Number of units transfused per patient	Up to the end of follow up visit (4 to 8 weeks)
Drainage volume	Until removal of drains
Number of units of blood or packed red cells transfused	Up to the end of follow up visit (4 to 8 weeks)
Change from pre-operative to post-operative hemoglobin concentration	At day 3 or earlyer prior to transfusion
Surgeon's assessment of obscurement of operative field by bleeding	Up to the end of follow up visit (4 to 8 weeks)