drugset / Trial / NCT01008436
Blood Sparing Strategies: Omni-stat Routinary Use in Cardiac Surgery. A Prospective Randomized Study.
RandomizedParallel-groupDouble-blindTreatment
Summary
The study enrolles all consecutive patients undergoing cardiac surgery at the European Hospital, Rome. The population undergoes randomization to receive usual surgical hemostasis or added topical application of Omni-stat Celox. The two populations are followed up prospectively as regarding blood loss and need for blood transfusions, as well as adverse events at 30 days after surgery.
Timeline
- Start
- 2010-01
- Primary completion
- 2010-08
- Completion
- 2010-09
Outcome
Outcome not reported
Stopped: “Lack of product due to industrial changes in the manufacturing process altering the final product.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omni-stat Celox | Unknown | 6 g | Topical |