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 (Blood-in-drape)

C

Centre Hospitalier Universitaire, Amiens

Status

Completed

Conditions

Heart Surgery

Treatments

Procedure: heart surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT02421003
PI2014_843_0017

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Patients
Experimental group
Description:
Patients undergoing heart surgery
Treatment:
Procedure: heart surgery

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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