NCT02421003

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	heart surgery

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-04-20
• Last updated: 2016-08-03

Locations

1 site across 1 country: France