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

Bayer

Status and phase: Terminated; Phase 3

Conditions: Blood Loss, Surgical

Treatments: Drug: Placebo; Drug: Trasylol (Aprotinin, BAYA0128)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00306137

EudraCT: 2005-004689-18

11800

Details and patient eligibility

About

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

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Trasylol (Aprotinin, BAYA0128)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo