Heart SurgerySPONCT02712879
Moderate Bleeding in Cardiac Surgery Post Operative
An observational study of Heart Surgery, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Surgery
- How many people
- 303 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2016to 30 Jun 2016
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted to intensive care after surgery for heart surgery
Who may be able to join
- Patients in the postoperative intensive care in cardiac surgery
Who cannot join
- Patients who received a heart transplant, a heart surgery beating, cardiac support establishment of long duration, or have a disease that alters the coagulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bleeding Moderate Postoperative Cardiac Surgery and Prognostic Implications Anemia and Postoperative Transfusion: Prospective, Observational, Descriptive.
Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population.
Read the detailed description
Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population.
Secondary objectives:
To evaluate the kinetics of moderate SPORT and its impact on anemia and postoperative transfusion.
To evaluate the prognostic impact of the SPO moderate in terms of post-operative complications.
Determine predictors of moderate SPO.
- Conditions
- Heart Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of blood loss per hour drains
Hourly blood loss in drains during the first twelve hours
Measured: Hourly blood loss in drains during the first twelve hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start11 Mar 2016
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marine SAOUR, CCA, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712879
- Sponsor's protocol ID
- UF9695
- Acronym
- SPO
- Status last verified
- Apr 2022
- First submitted
- 4 Mar 2016
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding Moderate Postoperative Cardiac Surgery and Prognostic Implications Anemia and Postoperative Transfusion: Prospective, Observational, Descriptive.
- ClinicalTrials.gov ID
- NCT02712879
- Acronym / sponsor ID
- SPO / UF9695
- Conditions
- Heart Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 11 Mar 2016 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 18 Mar 2016 (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.
Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population.
Detailed description
Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population.
Secondary objectives:
To evaluate the kinetics of moderate SPORT and its impact on anemia and postoperative transfusion.
To evaluate the prognostic impact of the SPO moderate in terms of post-operative complications.
Determine predictors of moderate SPO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to intensive care after surgery for heart surgery
Key inclusion criteria (1 listed)
- Patients in the postoperative intensive care in cardiac surgery
Key exclusion criteria (1 listed)
- Patients who received a heart transplant, a heart surgery beating, cardiac support establishment of long duration, or have a disease that alters the coagulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evolution of blood loss per hour drains
Time frame: Hourly blood loss in drains during the first twelve hours
Hourly blood loss in drains during the first twelve hours
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 20 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Marine SAOUR, CCA principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Surgery, run by University Hospital, Montpellier 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 1 inclusion and 1 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 20 Apr 2022. 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?
Evolution of blood loss per hour drains (time frame: Hourly blood loss in drains during the first twelve hours). 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 20 Apr 2022.