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

NCT01008436 — Not applicable, Terminated, 400 participants, Cardiochirurgia E.H.
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RegistryNCT01008436
StatusTerminated - Lack of product due to industrial changes in the manufacturing process altering the final product.
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment400 (Actual)
SponsorCardiochirurgia E.H. (Other)
ConditionsHemostasis
InterventionsOmni-stat Celox, Control (Drug)
Datesstart 2010-01-01, primary completion 2010-08-01, completion 2010-09-01, first posted 2009-11-05, last updated 2012-02-22
Locations1 site in Italy

Related Papers Related Patents Related Grants Related Experts
All trials for Hemostasis All trials of Omni-stat Celox All trials of Control

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
ControlActive comparatorDrug: ControlTraditional best-practice surgical hemostasis
Omni-stat CeloxExperimentalDrug: Omni-stat CeloxAdministration of 6 gr of Omni-stat Celox intraoperatively at the time of Hemostasis
  • Omni-stat Celox (Drug): Topical administration of 6 gr of Omnistat Celox
  • Control (Drug): Traditional surgical Hemostasis

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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]

+Eligibility

Sex: All

Inclusion Criteria:

* All patients undergoing heart surgery

Exclusion Criteria:

* None

+Locations (1)

FacilityCityCountryStatus
European HospitalRomeItaly