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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL. |
| |
| unanticipated bleeding | Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unanticipated Bleeding | From arrival in operating room until the patients leave post anesthesia care unit | one day |
| Measure | Description | Time Frame |
|---|---|---|
| Transfusions | transfusion pattern in the whole cohort | one day |
| Preoperative Anemia | proportion of patients with preoperative anemia |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients scheduled for surgery (expect cardiac, pediatric, and emergency surgery)
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Luc Hanouz, M.D.,Ph.D. | University Hospital, Caen | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL. Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL. |
| FG001 | Unanticipated Bleeding | Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL. Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL. |
| FG002 | No Significant Bleeding | Patients in whom surgery did not resulted in significant bleeding |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL. Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Unanticipated Bleeding | From arrival in operating room until the patients leave post anesthesia care unit | Posted | Number | percentage of participants | one day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL. Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jean-Luc Hanouz | CHU de Caen | 2 31 06 47 36 | 33 | hanouz-jl@chu-caen.fr |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unanticipated bleeding | Other | Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL. |
|
| one day |
| Lowest Hemoglobin | lowest peroperative hemoglobin concentration | one day |
| Unanticipated Bleeding |
Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL. Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL. |
| BG002 | No Peroperative Significant Bleeding | Patients for whom surgery did not result in significant bleeding |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ASA class | ASA class reported in number of patients in a 4 class scale as defined by the American Society of anesthesiologists ASA 1 : otherwise healthy patient ASA 2 : A patient with mild systemic disease ASA 3 : A patient with severe systemic disease ASA 4 : A patient with severe systemic disease that is a constant threat to life | Number | participants |
|
| body mass index | Mean | Standard Deviation | kg/m^2 |
|
| red blood cell pre-planned (yes/no) | Number | participants |
|
| Units of packed red blood cell pre planned (number) | Median | Inter-Quartile Range | units of packed red blood cell |
|
| OG002 | No Significant Bleeding | Patients in whom surgery did not resulted in significant bleeding |
|
|
| Secondary | Transfusions | transfusion pattern in the whole cohort | Posted | Number | number of participants | one day |
|
|
|
| Secondary | Preoperative Anemia | proportion of patients with preoperative anemia | Not Posted | one day |
| Secondary | Lowest Hemoglobin | lowest peroperative hemoglobin concentration | Not Posted | one day |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Unanticipated Bleeding | Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL. Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL. | 0 | 0 | 0 | 0 |
| EG002 | No Peroperative Significant Bleeding | Patients for whom surgery did not result in significant bleeding | 0 | 0 | 0 | 0 |
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