Blood-in-drape: 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

• Sponsor: Centre Hospitalier Universitaire, Amiens (Other)
• Overall Status: Completed
• CT.gov ID: NCT02421003
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Duration (Months): 5.9
• Patients Per Site Per Month: 10.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Surgery	Procedure: heart surgery	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: 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 Start Date: Jan 1, 2015
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients Patients undergoing heart surgery	Procedure: heart surgery

Outcome Measures

Primary Outcome Measures

1. Measurement of red blood cell numeration from blood collected. [Between the incision and the closure.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire d'Amiens	Amiens	Picardie	France	80054

Sponsors and Collaborators

• Centre Hospitalier Universitaire, Amiens

Investigators

• Principal Investigator: Gilles TOUATI, Doctor, CHU Amiens

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT02421003
• Other Study ID Numbers: PI2014_843_0017
• First Posted: Apr 20, 2015
• Last Update Posted: Aug 3, 2016
• Last Verified: Aug 1, 2016

• Keywords provided by Centre Hospitalier Universitaire, Amiens: heart surgery blood

Study Results

No Results Posted as of Aug 3, 2016