Clinical trial NCT00306137: Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Blood Loss, Surgical
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-03-23
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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)

Primary outcomes:
measure: Percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period
timeFrame: Up to the end of follow up visit (4 to 8 weeks)
Secondary outcomes:
measure: Number of units of blood or packed red cells transfused
timeFrame: Up to the end of follow up visit (4 to 8 weeks)
measure: Number of units transfused per patient
timeFrame: Up to the end of follow up visit (4 to 8 weeks)
measure: Intra-operative blood loss
timeFrame: Intra-operative
measure: Drainage volume
timeFrame: Until removal of drains
measure: Transfusion of platelets, colloids and plasma
timeFrame: Up to the end of follow up visit (4 to 8 weeks)
measure: Change from pre-operative to post-operative hemoglobin concentration
timeFrame: At day 3 or earlyer prior to transfusion
measure: Surgeon's assessment of obscurement of operative field by bleeding
timeFrame: Up to the end of follow up visit (4 to 8 weeks)
measure: Blood markers of inflammation and coagulation
timeFrame: Up to the end of follow up visit (4 to 8 weeks)
measure: Time to discontinuation of mechanical ventilation
timeFrame: Until removal of mechanical ventilation
measure: Health related quality of life measurements
timeFrame: Up to the end of follow up visit (4 to 8 weeks)
Other outcomes:
Locations:
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Boston
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Missouri
city: Durham
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: ask Contact
country: Australia
city: ask Contact
country: Austria
city: ask Contact
country: Belgium
city: ask Contact
country: Canada
city: ask Contact
country: Denmark
city: ask Contact
country: France
city: ask Contact
country: Germany
city: ask Contact
country: Spain
city: ask Contact
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: