drugset / Trial / NCT00816023
A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to assess the efficacy and identify the optimal dose(s) of ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery including the use of cardio pulmonary bypass.
Timeline
- Start
- 2009-03
- Primary completion
- 2009-12
- Completion
- 2010-01
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Ecallantide Low Dose vs Ecallantide Medium Dose vs Ecallantide High Dose vs Placebo; p = 0.474; Jonckheere-Terpstra NCT00816023 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ecallantide | Protein / enzyme biologic | — | Intravenous |
Indications
No indication recorded.