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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2005-004689-18 |
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Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trasylol (Aprotinin, BAYA0128) | Drug | Subjects successfully meeting all screening criteria 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 aprotinin was supplied in infusion vials of 200mL solution containing 2,000,000 KIU (10,000 KIU/mL) in 0.9% sodium chloride. Subjects will be stratified into one of the 4 following strata:
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period | Up to the end of follow up visit (4 to 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of units of blood or packed red cells transfused | Up to the end of follow up visit (4 to 8 weeks) | |
| Number of units transfused per patient | Up to the end of follow up visit (4 to 8 weeks) | |
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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 |
|---|---|---|---|---|---|---|
| Atlanta | Georgia | 30322 | United States | |||
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| Label | URL |
|---|---|
| Click here and search for product information provided by EMA | View source |
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|
| Placebo | Drug | Placebo solution was supplied in identical vials and will consist of 200mL of 0.9% sodium chloride. |
|
| Intra-operative blood loss |
| Intra-operative |
| Drainage volume | Until removal of drains |
| Transfusion of platelets, colloids and plasma | Up to the end of follow up visit (4 to 8 weeks) |
| Change from pre-operative to post-operative hemoglobin concentration | At day 3 or earlyer prior to transfusion |
| Surgeon's assessment of obscurement of operative field by bleeding | Up to the end of follow up visit (4 to 8 weeks) |
| Blood markers of inflammation and coagulation | Up to the end of follow up visit (4 to 8 weeks) |
| Time to discontinuation of mechanical ventilation | Until removal of mechanical ventilation |
| Health related quality of life measurements | Up to the end of follow up visit (4 to 8 weeks) |
| Augusta |
| Georgia |
| 30912 |
| United States |
| Indianapolis | Indiana | 46202 | United States |
| Indianapolis | Indiana | 46260 | United States |
| Boston | Massachusetts | 02115-6195 | United States |
| St Louis | Missouri | 63110-1094 | United States |
| Durham | North Carolina | 27710 | United States |
| Cleveland | Ohio | 44106-2602 | United States |
| Pittsburgh | Pennsylvania | 15213-2592 | United States |
| Houston | Texas | 77030 | United States |
| Salt Lake City | Utah | 84108 | United States |
| Charlottesville | Virginia | 22908 | United States |
| Ask Contact | Australia |
| Ask Contact | Austria |
| Ask Contact | Belgium |
| Ask Contact | Canada |
| Ask Contact | Denmark |
| Ask Contact | France |
| Ask Contact | Germany |
| Ask Contact | Spain |
| Ask Contact | United Kingdom |
| 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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