SurgeryNCT02311309
Epidemiology of Severe Peroperative Bleeding During Scheduled Surgery
An observational study of Surgery and Blood Loss, run by University Hospital, Caen.
Trial summary
Peroperative bleeding has been studied in specific populations exposed to bleeding (i.e. cardiac surgery, orthopedic surgery). Epidemiology of peroperative bleeding and transfusion remain poorly studied in the whole cohort of patients scheduled for surgery remain unknown. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Surgery, Blood Loss
- What is being tested?
- Unanticipated bleeding
- How many people
- 1,439 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Mar 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients scheduled for surgery (expect cardiac, pediatric, and emergency surgery)
Who may be able to join
- Patient scheduled for non cardiac and non emergency surgery
Who cannot join
- Cardiac surgery
- Emergency surgery
About this study
Official title: Epidemiology of Peroperative Bleeding and Transfusion During Scheduled Surgery.
Peroperative bleeding has been studied in specific populations exposed to bleeding (i.e. cardiac surgery, orthopedic surgery). Epidemiology of peroperative bleeding and transfusion remain poorly studied in the whole cohort of patients scheduled for surgery remain unknown. The investigators conducted a prospective study in order to examine the incidence, and risk factors associated with peroperative bleeding and transfusion.
Read the detailed description
This was a prospective observational including all consecutive patients scheduled for surgery during a 3 month period.
Exclusion criteria were : emergency, cardiac surgery, and pediatric surgery. Patients received an oral information and informed consent was search for all of them.
Throughout the study period (3 months) data were prospectively recorded by members of a specific research team not involved in the care of patients. Preoperative, peroperative and immediate postoperative data (post anesthesia care unit) were collected.
Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.
- Conditions
- Surgery, Blood Loss
- Being tested
- Control, Unanticipated bleeding
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL.
Unanticipated bleedingOther
Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL.
| Study group | Role | What they receive |
|---|---|---|
| control | Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL. Receives: Other: Control | |
| unanticipated bleeding | Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL. Receives: Other: Unanticipated bleeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unanticipated Bleeding
From arrival in operating room until the patients leave post anesthesia care unit
Measured: one day
Secondary outcomes (3)
Transfusions
transfusion pattern in the whole cohort
Measured: one day
Preoperative Anemia
proportion of patients with preoperative anemia
Measured: one day
Lowest Hemoglobin
lowest peroperative hemoglobin concentration
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startNov 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,439 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Hanouz, M.D.,Ph.D., Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311309
- Sponsor's protocol ID
- A13-D48-VOL.19
- Status last verified
- Mar 2016
- First submitted
- 4 Dec 2014
- Last updated
- 21 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Peroperative Bleeding and Transfusion During Scheduled Surgery.
- ClinicalTrials.gov ID
- NCT02311309
- Acronym / sponsor ID
- A13-D48-VOL.19
- Conditions
- Surgery, Blood Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,439 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Posted 21 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peroperative bleeding has been studied in specific populations exposed to bleeding (i.e. cardiac surgery, orthopedic surgery). Epidemiology of peroperative bleeding and transfusion remain poorly studied in the whole cohort of patients scheduled for surgery remain unknown. The investigators conducted a prospective study in order to examine the incidence, and risk factors associated with peroperative bleeding and transfusion.
Detailed description
This was a prospective observational including all consecutive patients scheduled for surgery during a 3 month period.
Exclusion criteria were : emergency, cardiac surgery, and pediatric surgery. Patients received an oral information and informed consent was search for all of them.
Throughout the study period (3 months) data were prospectively recorded by members of a specific research team not involved in the care of patients. Preoperative, peroperative and immediate postoperative data (post anesthesia care unit) were collected.
Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | Other: ControlPatients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL. |
| unanticipated bleeding | – | Other: Unanticipated bleedingUnanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients scheduled for surgery (expect cardiac, pediatric, and emergency surgery)
Key inclusion criteria (1 listed)
- Patient scheduled for non cardiac and non emergency surgery
Key exclusion criteria (2 listed)
- Cardiac surgery
- Emergency surgery
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 |
|---|---|---|
| ControlControl patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL. | Other | control |
| Unanticipated bleedingUnanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL. | Other | unanticipated bleeding |
Primary outcome
Unanticipated Bleeding
Time frame: one day
From arrival in operating room until the patients leave post anesthesia care unit
3 secondary outcomes
Transfusions
Time frame: one day
Preoperative Anemia
Time frame: one day
Lowest Hemoglobin
Time frame: one day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jean-Luc Hanouz, M.D.,Ph.D. principal investigator
University Hospital, Caen
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Blood Loss, run by University Hospital, Caen.
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 2 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 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 21 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Unanticipated Bleeding (time frame: one day). 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 21 Apr 2016.