Blood Loss, Surgery
Conditions
Brief 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. 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.
Interventions
OTHERControl
Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration \>8 g/dL.
OTHERUnanticipated bleeding
Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration \< 8 g/dL.
Sponsors
University Hospital, Caen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient scheduled for non cardiac and non emergency surgery
Exclusion criteria
* Cardiac surgery * Emergency surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unanticipated Bleeding | one day | From arrival in operating room until the patients leave post anesthesia care unit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative Anemia | one day | proportion of patients with preoperative anemia |
| Lowest Hemoglobin | one day | lowest peroperative hemoglobin concentration |
| Transfusions | one day | transfusion pattern in the whole cohort |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 541 |
| 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. | 35 |
| No Peroperative Significant Bleeding Patients for whom surgery did not result in significant bleeding | 863 |
| Total | 1,439 |
Baseline characteristics
| Characteristic | Control | Unanticipated Bleeding | No Peroperative Significant Bleeding | Total |
|---|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 17 | 66 years STANDARD_DEVIATION 16 | 53 years STANDARD_DEVIATION 19 | 56 years STANDARD_DEVIATION 18 |
| ASA class ASA Class 1 | 107 participants | 2 participants | 261 participants | 370 participants |
| ASA class ASA Class 2 | 283 participants | 18 participants | 448 participants | 749 participants |
| ASA class ASA Class 3 | 150 participants | 14 participants | 150 participants | 314 participants |
| ASA class ASA Class 4 | 1 participants | 1 participants | 4 participants | 6 participants |
| body mass index | 28 kg/m^2 STANDARD_DEVIATION 6 | 27 kg/m^2 STANDARD_DEVIATION 6 | 26 kg/m^2 STANDARD_DEVIATION 6 | 27 kg/m^2 STANDARD_DEVIATION 6 |
| red blood cell pre-planned (yes/no) No | 368 participants | 18 participants | 835 participants | 1221 participants |
| red blood cell pre-planned (yes/no) Yes | 173 participants | 17 participants | 28 participants | 218 participants |
| Sex: Female, Male Female | 254 Participants | 19 Participants | 405 Participants | 678 Participants |
| Sex: Female, Male Male | 287 Participants | 16 Participants | 458 Participants | 761 Participants |
| Units of packed red blood cell pre planned (number) | 3 units of packed red blood cell | 3 units of packed red blood cell | 2 units of packed red blood cell | 3 units of packed red blood cell |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Unanticipated Bleeding
From arrival in operating room until the patients leave post anesthesia care unit
Time frame: one day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Unanticipated Bleeding | 0 percentage of participants |
| Unanticipated Bleeding | Unanticipated Bleeding | 100 percentage of participants |
| No Significant Bleeding | Unanticipated Bleeding | 0 percentage of participants |
Secondary
Lowest Hemoglobin
lowest peroperative hemoglobin concentration
Time frame: one day
Secondary
Preoperative Anemia
proportion of patients with preoperative anemia
Time frame: one day
Secondary
Transfusions
transfusion pattern in the whole cohort
Time frame: one day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Transfusions | transfusion of pack red blood cell | 33 number of participants |
| Control | Transfusions | no transfusion | 508 number of participants |
| Unanticipated Bleeding | Transfusions | transfusion of pack red blood cell | 31 number of participants |
| Unanticipated Bleeding | Transfusions | no transfusion | 4 number of participants |
| No Significant Bleeding | Transfusions | transfusion of pack red blood cell | 1 number of participants |
| No Significant Bleeding | Transfusions | no transfusion | 862 number of participants |