Exploratory Study, Prospective, of Volume, Composition and Bacteriology of the Recovered Blood of Multi-perforated Catheter Inserted in the Drapes Thickness of Incisional Sternal Area During Heart Surgery

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-07-31

Brief Summary

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The recovered blood into the surgical site at the border of the fields, is very rich in red blood cells, due to the adjacency of the bone marrow and the sternum.

The blood recovered from the surgical site at the border of the fields, is richer in red blood cells than the bloodstream of the patient.

The recovered blood into the surgical site at the border of the fields, is not contaminated and bacteriological cultures are negative.

Consequences: The recovered blood in the surgical site at the edge of fields, can be recovered in the Saver® Cell for reprocessing and re-injected into the patient.

There isn't in our knowledge of published clinical data on the volume and composition of the recovered blood in the surgical site after cardiac surgery.

The analysis of the available literature does not allow to estimate the expected outcomes us. Therefore, this study will be exploratory in nature and will aim to estimate the volume and the content of red blood cells from blood recovered, and generate clinical data to be used in subsequent confirmatory tests.

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Detailed Description

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Conditions

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Heart Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patients

Patients undergoing heart surgery

Group Type EXPERIMENTAL

heart surgery

Intervention Type PROCEDURE

Interventions

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heart surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years;
* Any open heart surgery with or without extracorporeal circulation
* Signature of informed consent
* Affiliation to social security

Exclusion Criteria

* Subjects legally protected or unable to consent
* Persons deprived of liberty
* Cardiac Surgery extreme emergency (due to difficulties obtaining informed consent)
* Pregnant or breastfeeding women

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No