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

Cardiochirurgia E.H.400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

Hemostasis

Interventions

Omni-stat CeloxDRUG

Topical administration of 6 gr of Omnistat Celox

ControlDRUG

Traditional surgical Hemostasis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * All patients undergoing heart surgery Exclusion Criteria: * None

Locations (1)

European Hospital

Rome, Italy

Outcomes

Primary Outcomes

Number of blood units transfused to the patients after surgery till discharge

Time frame: 30 days

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 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.

Time frame: 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

Time frame: 1,2,3,5,7,10 minutes after application

Data from ClinicalTrials.gov

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