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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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02421003
Acronym
Blood-in-drape
Enrollment
60
Registered
2015-04-20
Start date
2015-01-31
Completion date
2015-07-31
Last updated
2016-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Surgery

Keywords

heart surgery blood

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.

Interventions

PROCEDUREheart surgery

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Measurement of red blood cell numeration from blood collected.Between the incision and the closure.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026