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
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)
Number of units transfused per patient	Up to the end of follow up visit (4 to 8 weeks)
Number of units of blood or packed red cells transfused	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)
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)
Blood markers of inflammation and coagulation	Up to the end of follow up visit (4 to 8 weeks)
Drainage volume	Until removal of drains