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

Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Blood Loss, Surgical

Intervention: Trasylol (Aprotinin, BAYA0128) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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 design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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)

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.

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.

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.

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

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.

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

Surgeon's assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures.

Changes in blood markers related to inflammation and blood coagulation

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects 18 years of age and older

- Subjects requiring elective primary total hip replacement surgery

- Documented, signed, dated informed consent obtained prior to any study specific

procedures being performed. Standard care procedures performed within 30 days of screening (including safety labs, ECG and PE) will be allowed to qualify a patient for study entry once the informed consent has been signed.

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

Locations and Contacts

Quebec G1L 3L5, Canada

Birmingham, Alabama 35205, United States

Mobile, Alabama 36608, United States

Edmonton, Alberta T6G 2B7, Canada

Phoenix, Arizona 85023, United States

Vancouver, British Columbia V6Z 1Y6, Canada

La Jolla, California 92037, United States

Aurora, Colorado 80012, United States

Farmington, Connecticut 06032, United States

St. Petersburg, Florida 33703, United States

Jacksonville Beach, Florida 32250, United States

Bay Pines, Florida 33744, United States

Mooresville, Indiana 46158, United States

Baltimore, Maryland 21215, United States

Worcester, Massachusetts 01655, United States

Kalamazoo, Michigan 49009, United States

Ypsilanti, Michigan 48197, United States

Greensboro, North Carolina 27401, United States

Halifax, Nova Scotia B3H 3A7, Canada

Oshawa, Ontario L1J 2J2, Canada

Oshawa, Ontario L1G 2B9, Canada

London, Ontario N6A 5A5, Canada

Kitchener, Ontario N2G 1G3, Canada

Bend, Oregon 97701, United States

Pittsburgh, Pennsylvania 15213-2592, United States

Philadelphia, Pennsylvania 19107, United States

Lubbock, Texas 79410, United States

Additional Information

Click here to find results for studies related to marketed products

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Starting date: February 2005
Ending date: January 2006
Last updated: April 27, 2008

Page last updated: June 20, 2008

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