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

Purpose

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

Condition	Intervention	Phase
Blood Loss, Surgical	Drug: Trasylol (Aprotinin, BAYA0128) Drug: Placebo	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Aprotinin

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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) ]

Secondary Outcome Measures:

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 [ Time Frame: Up to the end of follow up visit (4 to 8 weeks) ]

Enrollment:	101
Study Start Date:	December 2005
Study Completion Date:	March 2007

Arms	Assigned Interventions
Experimental: Arm 1	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 Comparator: Arm 2	Drug: Placebo Placebo solution was supplied in identical vials and will consist of 200mL of 0.9% sodium chloride.

Arms

Assigned Interventions

Experimental: Arm 1

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 Comparator: Arm 2

Drug: Placebo

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306137

Show 21 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00306137 History of Changes
Other Study ID Numbers:	11800, EudraCT: 2005-004689-18
Study First Received:	March 21, 2006
Last Updated:	May 7, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Esophageal Neoplasms
Hemorrhage
Blood Loss, Surgical
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Pathologic Processes

Intraoperative Complications
Aprotinin
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013