Trial | NCT01008436  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    400
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.
Study Started
Jan 31
2010
Primary Completion
Aug 31
2010
Study Completion
Sep 30
2010
Last Update
Feb 22
2012
Estimate

Drug Omni-stat Celox

Topical administration of 6 gr of Omnistat Celox

Drug Control

Traditional surgical Hemostasis

Control Active Comparator

Traditional best-practice surgical hemostasis

Omni-stat Celox Experimental

Administration of 6 gr of Omni-stat Celox intraoperatively at the time of Hemostasis

Criteria 

Inclusion Criteria:

All patients undergoing heart surgery

Exclusion Criteria:

None
No Results Posted