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

NCT02421003 | Completed

• 1 other identifier: PI2014_843_0017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Surgery

Keywords

heart surgery blood

Outcome Measures

Primary Outcomes (1)

• Measurement of red blood cell numeration from blood collected.

  Between the incision and the closure.

Study Arms (1)

Patients

EXPERIMENTAL

Patients undergoing heart surgery

Procedure: heart surgery

Interventions

heart surgery PROCEDURE

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, 80054, France

Location

MeSH Terms

Interventions

Cardiac Surgical Procedures

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Gilles TOUATI, Doctor

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: April 20, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 3, 2016

Record last verified: 2016-08

Locations

FR (1)