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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00668031
First received: April 22, 2008
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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.


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, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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) [ Time Frame: intra-op tp discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: surgery to discharge ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: surgery to discharge ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: surgery to discharge ] [ Designated as safety issue: No ]
  • The number of units of blood or packed red cells transfused per patient requiring transfusion. [ Time Frame: surgery to discharge ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: surgery to discharge ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: pre-operative through day 2 ] [ Designated as safety issue: No ]
  • Surgeon's assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures. [ Time Frame: surgery ] [ Designated as safety issue: No ]
  • Changes in blood markers related to inflammation and blood coagulation [ Time Frame: surgery to discharge ] [ Designated as safety issue: No ]

Enrollment: 360
Study Start Date: February 2005
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 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 Comparator: Arm 2 Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668031

  Show 40 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00668031     History of Changes
Other Study ID Numbers: 11694
Study First Received: April 22, 2008
Last Updated: October 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Transfusion requirements
Hip replacement surgery
Prevention of blood loss
Bloodloss

Additional relevant MeSH terms:
Hemorrhage
Blood Loss, Surgical
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 July 22, 2014