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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Elec

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.

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • 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 ]
  • 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 ]
  • The number of units of blood or packed red cells transfused per patient requiring transfusion. [ Time Frame: surgery to discharge ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Changes in blood markers related to inflammation and blood coagulation [ Time Frame: surgery to discharge ]


Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: April 22, 2008
Date Started: February 2005
Date Completion:
Last Updated: December 26, 2014
Last Verified: December 2014