Blood Sparing Strategies: Omni-stat Routinary Use in Cardiac Surgery. A Prospective Randomized Study.
Not Applicable
Terminated
- Conditions
- Hemostasis
- Interventions
- Drug: Omni-stat CeloxDrug: Control
- Registration Number
- NCT01008436
- Lead Sponsor
- Cardiochirurgia E.H.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- All patients undergoing heart surgery
Exclusion Criteria
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Omni-stat Celox Omni-stat Celox Administration of 6 gr of Omni-stat Celox intraoperatively at the time of Hemostasis Control Control Traditional best-practice surgical hemostasis
- Primary Outcome Measures
Name Time Method Number of blood units transfused to the patients after surgery till discharge 30 days Percentage of acute bleeding controlled by Hemostasis Tool (surgical technique or Omnistat application) in the defined time frame of 10 minutes 10 minutes
- Secondary Outcome Measures
Name Time Method Time needed to achieve Hemostasis using Omnistat as regarding to defined time frames of 1,2,3,5,7,10 minutes 1,2,3,5,7,10 minutes after application 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. 3, 6, 12, 24 hours
Trial Locations
- Locations (1)
European Hospital
🇮🇹Rome, Italy