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

Cardiochirurgia E.H.

Status: Terminated

Conditions: Hemostasis

Treatments: Drug: Control; Drug: Omni-stat Celox

Study type: Interventional

Funder types: Other

Identifiers

NCT01008436

00-03

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients undergoing heart surgery

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups

Control

Active Comparator group

Description:

Traditional best-practice surgical hemostasis

Treatment:

Drug: Control

Omni-stat Celox

Experimental group

Description:

Administration of 6 gr of Omni-stat Celox intraoperatively at the time of Hemostasis

Treatment:

Drug: Omni-stat Celox