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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35205 | United States | |||
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| 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 |
|
| 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. | surgery to discharge |
| The number of units of blood or packed red cells transfused per patient requiring transfusion. | 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. | 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 | 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. | surgery |
| Changes in blood markers related to inflammation and blood coagulation | surgery to discharge |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Phoenix | Arizona | 85023 | United States |
| La Jolla | California | 92037 | United States |
| San Diego | California | 92123 | United States |
| Aurora | Colorado | 80012 | United States |
| Farmington | Connecticut | 06032 | United States |
| Bay Pines | Florida | 33744 | United States |
| Jacksonville Beach | Florida | 32250 | United States |
| Sarasota | Florida | 34239 | United States |
| St. Petersburg | Florida | 33703 | United States |
| Boise | Idaho | 83702 | United States |
| Indianapolis | Indiana | 46260 | United States |
| Mooresville | Indiana | 46158 | United States |
| Iowa City | Iowa | 52242-1089 | United States |
| Baltimore | Maryland | 21215 | United States |
| Worcester | Massachusetts | 01655 | United States |
| Kalamazoo | Michigan | 49009 | United States |
| Ypsilanti | Michigan | 48197 | United States |
| Durham | North Carolina | 27710 | United States |
| Greensboro | North Carolina | 27401 | United States |
| Bend | Oregon | 97701 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Pittsburgh | Pennsylvania | 15213-2592 | United States |
| Dallas | Texas | 75231 | United States |
| Lubbock | Texas | 79410 | United States |
| San Antonio | Texas | 78233 | United States |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Kelowna | British Columbia | V1Y 1T2 | Canada |
| Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Fredericton | New Brunswick | E3B 5N5 | Canada |
| Halifax | Nova Scotia | B3H 3A7 | Canada |
| Guelph | Ontario | N1E 4J4 | Canada |
| Kitchener | Ontario | N2G 1G3 | Canada |
| London | Ontario | N6A 5A5 | Canada |
| Oshawa | Ontario | L1G 2B9 | Canada |
| Oshawa | Ontario | L1J 2J2 | Canada |
| Richmond Hill | Ontario | L4C 4Z3 | Canada |
| Québec | Quebec | G1L 3L5 | Canada |
| San Juan | 00935 | Puerto Rico |
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| ID | Term |
|---|---|
| D007611 | Aprotinin |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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