Hemostasis
Conditions
Keywords
Ability of topical drug to reduce acute and overall bleeding as well as blood transfusions
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.
Interventions
DRUGOmni-stat Celox
Topical administration of 6 gr of Omnistat Celox
DRUGControl
Traditional surgical Hemostasis
Sponsors
Cardiochirurgia E.H.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients undergoing heart surgery
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
Italy
Outcome results
None listed