Heart SurgeryBlood-in-drapeNCT02421003
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
A study testing heart surgery in people with Heart Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Surgery
- What is being tested?
- heart surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Any open heart surgery with or without extracorporeal circulation
- Signature of informed consent
- Affiliation to social security
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- heart surgery
- Keywords
- heart surgery blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients undergoing heart surgery Receives: Procedure: heart surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of red blood cell numeration from blood collected.
Measured: Between the incision and the closure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles TOUATI, Doctor, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421003
- Sponsor's protocol ID
- PI2014_843_0017
- Acronym
- Blood-in-drape
- Status last verified
- Aug 2016
- First submitted
- 10 Apr 2015
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02421003
- Acronym / sponsor ID
- Blood-in-drape / PI2014_843_0017
- Conditions
- Heart Surgery
- Keywords
- heart surgery blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: heart surgeryPatients undergoing heart surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Any open heart surgery with or without extracorporeal circulation
- Signature of informed consent
- Affiliation to social security
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heart surgery | Procedure or surgery | Patients |
Primary outcome
Measurement of red blood cell numeration from blood collected.
Time frame: Between the incision and the closure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles TOUATI, Doctor principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heart surgery in people with Heart Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of red blood cell numeration from blood collected. (time frame: Between the incision and the closure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016.