Blood Sparing Strategies: Omni-stat Routinary Use in Cardiac Surgery. A Prospective Randomized Study.
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|ClinicalTrials.gov Identifier: NCT01008436|
Recruitment Status : Terminated (Lack of product due to industrial changes in the manufacturing process altering the final product.)
First Posted : November 5, 2009
Last Update Posted : February 22, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Hemostasis||Drug: Omni-stat Celox Drug: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||September 2010|
Active Comparator: Control
Traditional best-practice surgical hemostasis
Traditional surgical Hemostasis
Experimental: Omni-stat Celox
Administration of 6 gr of Omni-stat Celox intraoperatively at the time of Hemostasis
Drug: Omni-stat Celox
Topical administration of 6 gr of Omnistat Celox
- Number of blood units transfused to the patients after surgery till discharge [ Time Frame: 30 days ]
- Percentage of acute bleeding controlled by Hemostasis Tool (surgical technique or Omnistat application) in the defined time frame of 10 minutes [ Time Frame: 10 minutes ]
- Blood volume collected in chest drains expressed in milliliters, with partial totals 3, 6 and 12 hours after surgery and final total 24 hours after surgery. [ Time Frame: 3, 6, 12, 24 hours ]
- Time needed to achieve Hemostasis using Omnistat as regarding to defined time frames of 1,2,3,5,7,10 minutes [ Time Frame: 1,2,3,5,7,10 minutes after application ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008436
|Rome, Italy, 00152|