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

NCT ID: NCT01008436

Last Updated: 2012-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hemostasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

Traditional best-practice surgical hemostasis

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DRUG

Traditional surgical Hemostasis

Omni-stat Celox

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

Group Type EXPERIMENTAL

Omni-stat Celox

Intervention Type DRUG

Topical administration of 6 gr of Omnistat Celox

Interventions

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Omni-stat Celox

Topical administration of 6 gr of Omnistat Celox

Intervention Type DRUG

Control

Traditional surgical Hemostasis

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing heart surgery

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiochirurgia E.H.

OTHER

Sponsor Role lead

Responsible Party

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Luca Weltert

Project Leader Luca Weltert

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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European Hospital

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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00-03

Identifier Type: -

Identifier Source: org_study_id

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