drugset / Trial / NCT01008436

Blood Sparing Strategies: Omni-stat Routinary Use in Cardiac Surgery. A Prospective Randomized Study.

NCT01008436 ↗

Terminated 400 enrolled Cardiochirurgia E.H.
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

EvaluationDrugModalityDoseRoute
Subject Omni-stat Celox Unknown 6 g Topical