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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-004055-35 | EudraCT Number |
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The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder 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 | Subjects will be randomized to receive an infusion of aprotinin (a test dose followed by a loading dose of 2 million KIU before skin incision followed by 500,000 KIU/hour until the end of surgery) or matching placebo. The maximal dose of aprotinin, that can be administered is 7,000,000 KIU, regardless of the duration of the operation. When a total of 7 million has been reached the administration of aprotinin must be discontinued. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary criterion for efficacy is the percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge) | Anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge) |
| Measure | Description | Time Frame |
|---|---|---|
| The number of units of blood or packed red cells transfused. There will be an analysis for the combination of autologous and allogenic transfusion and for allogenic alone | Intra- and postoperative | |
| The number of units of blood or packed red cells transfused per patient requiring transfusion |
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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 |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90095 | United States | |||
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| Label | URL |
|---|---|
| Click here and search for information of Bayer products for Europe | View source |
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|
| Placebo | Drug | Placebo is used according to the description of Arm 1 |
|
| Intra- and postoperative |
| The intraoperative blood loss determined as follow: a) by surgeon estimate b) summing weight of the blood in gauze and other materials and the suction drainage volume | Intraoperative |
| The drainage volume (in milliliters) from the operative site | In the first 8 hours post-operatively, and daily total drainage until removal of drains or until discharge, whichever comes first |
| Transfusion of platelets, colloids, plasma and number of patients requiring these products | Intra- and postoperative |
| The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration | Obtained in the morning of postoperative Day 3, 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 | Intraoperative |
| Changes in blood markers related to inflammation and blood coagulation; baseline until Discharge or day 7 | Several measurements from baseline up to 6 weeks |
| Time to discontinuing of mechanical ventilation | Not specifed |
| Changes in FEV1 | Baseline until Discharge or day7 |
| Changes in the patients health related quality of life (HRQoL) (at baseline and 6+-2 weeks post surgery) using the Functional Assessment Cancer Therapy for patients with Bladder cancer (FACT-Bl) questionnaire | At baseline and 6+-2 weeks post surgery |
| Denver |
| Colorado |
| 80262 |
| United States |
| Miami | Florida | 33125 | United States |
| Chicago | Illinois | 60612 | United States |
| Chicago | Illinois | 60637 | United States |
| Portland | Maine | 04102 | United States |
| Baltimore | Maryland | 21224 | United States |
| Ann Arbor | Michigan | 48109-0330 | United States |
| Rochester | Minnesota | 55905 | United States |
| Chapel Hill | North Carolina | 27599-7065 | United States |
| Cleveland | Ohio | 44106-2602 | United States |
| Columbus | Ohio | 43214-1419 | United States |
| Oklahoma City | Oklahoma | 73104 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Pittsburgh | Pennsylvania | 15213-2592 | United States |
| Nashville | Tennessee | 37232 | United States |
| Houston | Texas | 77030 | United States |
| Burlington | Vermont | 05401-1420 | United States |
| Ghent | 9000 | Belgium |
| Leuven | 3000 | Belgium |
| Nantes | 44035 | France |
| Nice | 06200 | France |
| Tübingen | Baden-Wurttemberg | 72076 | Germany |
| München | Bavaria | 81377 | Germany |
| Regensburg | Bavaria | 93053 | Germany |
| Fulda | Hesse | 36043 | Germany |
| Mainz | Rhineland-Palatinate | 55131 | Germany |
| Homburg | Saarland | 66421 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Maastricht | 6229 HX | Netherlands |
| Nijmegen | 6525 GA | Netherlands |
| Linköping | 581 85 | Sweden |
| Lund | 221 85 | Sweden |
| Stockholm | 171 76 | Sweden |
| Uppsala | 751 85 | Sweden |
| Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
| Newcastle upon Tyne | Tyne and Wear | NE7 7DN | United Kingdom |
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D007611 | Aprotinin |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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