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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Luca Weltert, 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.


Condition or disease Intervention/treatment Phase
Hemostasis Drug: Omni-stat Celox Drug: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
Active Comparator: Control
Traditional best-practice surgical hemostasis
Drug: Control
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




Primary Outcome Measures :
  1. Number of blood units transfused to the patients after surgery till discharge [ Time Frame: 30 days ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing heart surgery

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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


Locations
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Italy
European Hospital
Rome, Italy, 00152
Sponsors and Collaborators
Cardiochirurgia E.H.
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Responsible Party: Luca Weltert, Project Leader Luca Weltert, Cardiochirurgia E.H.
ClinicalTrials.gov Identifier: NCT01008436    
Other Study ID Numbers: 00-03
First Posted: November 5, 2009    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Keywords provided by Luca Weltert, Cardiochirurgia E.H.:
Ability of topical drug to reduce acute and overall bleeding as well as blood transfusions