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

Blood Loss, Surgical Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung Cancer or Esophageal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00306137
• Other study ID #: 11800
• Secondary ID: EudraCT: 2005-00
• Status: Terminated
• Phase: Phase 3
• First received: March 21, 2006
• Last updated: December 8, 2014
• Start date: December 2005
• Est. completion date: March 2007

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  France,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Number of units of blood or packed red cells transfused		Up to the end of follow up visit (4 to 8 weeks)	No
Secondary	Number of units transfused per patient		Up to the end of follow up visit (4 to 8 weeks)	No
Secondary	Intra-operative blood loss		Intra-operative	No
Secondary	Drainage volume		Until removal of drains	No
Secondary	Transfusion of platelets, colloids and plasma		Up to the end of follow up visit (4 to 8 weeks)	No
Secondary	Change from pre-operative to post-operative hemoglobin concentration		At day 3 or earlyer prior to transfusion	No
Secondary	Surgeon's assessment of obscurement of operative field by bleeding		Up to the end of follow up visit (4 to 8 weeks)	No
Secondary	Blood markers of inflammation and coagulation		Up to the end of follow up visit (4 to 8 weeks)	No
Secondary	Time to discontinuation of mechanical ventilation		Until removal of mechanical ventilation	No
Secondary	Health related quality of life measurements		Up to the end of follow up visit (4 to 8 weeks)	No

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