Trials / No Longer Available
No Longer AvailableNCT00611845
Aprotinin US Special Access Protocol
Aprotinin US Special Access Protocol: An Open Label, Non-Comparative Treatment Protocol for the Use of Aprotinin in Patients Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass Who Are at Increased Risk of Blood Loss and Transfusion
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a special access protocol that will allow physicians access to aprotinin during the temporary marketing suspension. The program will provide aprotinin for treatment of surgical patients undergoing coronary artery bypass graft (CABG) surgery requiring cardiopulmonary bypass (CPB) who are at increased risk of bleeding and transfusion when, in the opinion of the treating physician, the patients require it, there is no acceptable alternative therapy, and when there is a clearly favorable benefit-risk for the drug in that individual patient.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aprotinin (Trasylol, BAYA0128) | Trasylol at either 1,000,000 KIU or 2,000,000 KIU |
Timeline
- First posted
- 2008-02-11
- Last updated
- 2014-06-23
Locations
17 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00611845. Inclusion in this directory is not an endorsement.