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Completed

NCT Number: NCT00668031

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

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.

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Key information

Conditions

Blood Loss, Surgical Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trasylol (Aprotinin, BAYA0128)

Drug

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

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. The number of units of blood or packed red cells transfused per patient requiring transfusion.

    Time frame: surgery to discharge

  5. 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

  6. 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

  7. 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

  8. Changes in blood markers related to inflammation and blood coagulation

    Time frame: surgery to discharge

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Apr 28, 2008
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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