Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement

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 and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668031
• Other study ID #: 11694
• Status: Completed
• Phase: Phase 3
• First received: April 22, 2008
• Last updated: December 26, 2014
• Start date: February 2005
• Est. completion date: January 2006

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 359
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage

Intervention

Drug:
• Trasylol (Aprotinin, BAYA0128)
A loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of aprotinin using an IV infusion pump
• Placebo
A loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of of placebo using an IV infusion pump

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		intra-op tp discharge	No
Secondary	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.		surgery to discharge	No
Secondary	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.		surgery to discharge	No
Secondary	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.		surgery to discharge	No
Secondary	The number of units of blood or packed red cells transfused per patient requiring transfusion.		surgery to discharge	No
Secondary	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.		surgery to discharge	No
Secondary	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		pre-operative through day 2	No
Secondary	Surgeon's assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures.		surgery	No
Secondary	Changes in blood markers related to inflammation and blood coagulation		surgery to discharge	No

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