Clinical trial NCT00668031: Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blood Loss, Surgical
Keywords: Transfusion requirements
Hip replacement surgery
Prevention of blood loss
Bloodloss
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 359
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess if aprotinin (BAY A0128), given intravenously during surgery, is safe and can help reduce the amount of bleeding and the need for a blood transfusion during hip replacement surgery. Patients undergoing major surgery are at risk for significant blood loss. Because of this, there is a need for drugs that will help slow the amount of bleeding during surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects requiring elective primary total hip replacement surgery
* Documented, signed, 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. If the subject has undergone cardiac surgery in the last 6 months, all attempts should be made to ascertain if aprotinin was administered during cardiac surgery. If no records are available, subject should be excluded. If during cardiac surgery in the last 6 months, there is a record of aprotinin administration, subject should be excluded
* Subjects with a known or suspected allergy to aprotinin - Subjects with impaired renal function (serum creatinine \> 3.5 mg/dl or 309 micromoles/liter)
* Subjects with a history of bleeding diathesis or known coagulation factor deficiency
* Subjects with failure of a major organ system or any active significant medical illness that in the opinion of the investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
* Subjects who refuse to receive allogenic blood products for religious or other reasons

Primary outcomes:
measure: Percent of subjects requiring a blood transfusion (predonated blood or packed red blood cells, autologous or allogenic) anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
timeFrame: intra-op tp discharge
Secondary outcomes:
measure: The percent of subjects receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge.
timeFrame: surgery to discharge
measure: The percent of subjects who did and did not predonate blood receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge.
timeFrame: surgery to discharge
measure: The number of units of blood or packed red cells transfused. There will be analyses for the combination of autologous and allogenic transfusion and for allogenic alone.
timeFrame: surgery to discharge
measure: The number of units of blood or packed red cells transfused per patient requiring transfusion.
timeFrame: surgery to discharge
measure: The estimated blood loss during surgery, drainage (in milliliters) from the operative site in the first six hours post-operatively, and total drainage until removal of drains.
timeFrame: surgery to discharge
measure: The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of postoperative Day 2, or, if transfused earlier, prior to transfusion
timeFrame: pre-operative through day 2
measure: Surgeon's assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures.
timeFrame: surgery
measure: Changes in blood markers related to inflammation and blood coagulation
timeFrame: surgery to discharge
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: La Jolla
country: United States
state: California
city: San Diego
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Farmington
country: United States
state: Connecticut
city: Bay Pines
country: United States
state: Florida
city: Jacksonville Beach
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Indianapolis
country: United States
state: Indiana
city: Mooresville
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Baltimore
country: United States
state: Maryland
city: Worcester
country: United States
state: Massachusetts
city: Kalamazoo
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Durham
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Bend
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Edmonton
country: Canada
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Fredericton
country: Canada
state: New Brunswick
city: Halifax
country: Canada
state: Nova Scotia
city: Guelph
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Richmond Hill
country: Canada
state: Ontario
city: Quebec
country: Canada
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: