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

Hemostasis Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01008436
• Other study ID #: 00-03
• Status: Terminated
• Phase: N/A
• First received: November 3, 2009
• Last updated: February 19, 2012
• Start date: January 2010
• Est. completion date: September 2010

Study information

• Verified date: February 2012
• Source: Cardiochirurgia E.H.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients undergoing heart surgery

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemostasis

Intervention

Drug:
• Omni-stat Celox
Topical administration of 6 gr of Omnistat Celox
• Control
Traditional surgical Hemostasis

Locations

Country	Name	City	State
Italy	European Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Cardiochirurgia E.H.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of blood units transfused to the patients after surgery till discharge		30 days	No
Primary	Percentage of acute bleeding controlled by Hemostasis Tool (surgical technique or Omnistat application) in the defined time frame of 10 minutes		10 minutes	No
Secondary	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	No
Secondary	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	No