Trial Outcomes & Findings for Epidemiology of Severe Peroperative Bleeding During Scheduled Surgery (NCT NCT02311309)

NCT ID: NCT02311309

Last Updated: 2016-04-21

Results Overview

From arrival in operating room until the patients leave post anesthesia care unit

• Recruitment status: COMPLETED
• Target enrollment: 1439 participants
• Primary outcome timeframe: one day
• Results posted on: 2016-04-21

Participant Flow

Participant milestones

Measure	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.	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.	No Significant Bleeding Patients in whom surgery did not resulted in significant bleeding
Overall Study STARTED	541	35	863
Overall Study COMPLETED	541	35	863
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Epidemiology of Severe Peroperative Bleeding During Scheduled Surgery

Baseline characteristics by cohort

Measure	Control n=541 Participants 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.	Unanticipated Bleeding n=35 Participants 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.	No Peroperative Significant Bleeding n=863 Participants Patients for whom surgery did not result in significant bleeding	Total n=1439 Participants Total of all reporting groups
Age, Continuous	59 years STANDARD_DEVIATION 17 • n=5 Participants	66 years STANDARD_DEVIATION 16 • n=7 Participants	53 years STANDARD_DEVIATION 19 • n=5 Participants	56 years STANDARD_DEVIATION 18 • n=4 Participants
Sex: Female, Male Female	254 Participants n=5 Participants	19 Participants n=7 Participants	405 Participants n=5 Participants	678 Participants n=4 Participants
Sex: Female, Male Male	287 Participants n=5 Participants	16 Participants n=7 Participants	458 Participants n=5 Participants	761 Participants n=4 Participants
ASA class ASA Class 1	107 participants n=5 Participants	2 participants n=7 Participants	261 participants n=5 Participants	370 participants n=4 Participants
ASA class ASA Class 2	283 participants n=5 Participants	18 participants n=7 Participants	448 participants n=5 Participants	749 participants n=4 Participants
ASA class ASA Class 3	150 participants n=5 Participants	14 participants n=7 Participants	150 participants n=5 Participants	314 participants n=4 Participants
ASA class ASA Class 4	1 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants	6 participants n=4 Participants
body mass index	28 kg/m^2 STANDARD_DEVIATION 6 • n=5 Participants	27 kg/m^2 STANDARD_DEVIATION 6 • n=7 Participants	26 kg/m^2 STANDARD_DEVIATION 6 • n=5 Participants	27 kg/m^2 STANDARD_DEVIATION 6 • n=4 Participants
red blood cell pre-planned (yes/no) Yes	173 participants n=5 Participants	17 participants n=7 Participants	28 participants n=5 Participants	218 participants n=4 Participants
red blood cell pre-planned (yes/no) No	368 participants n=5 Participants	18 participants n=7 Participants	835 participants n=5 Participants	1221 participants n=4 Participants
Units of packed red blood cell pre planned (number)	3 units of packed red blood cell n=5 Participants	3 units of packed red blood cell n=7 Participants	2 units of packed red blood cell n=5 Participants	3 units of packed red blood cell n=4 Participants

PRIMARY outcome

Timeframe: one day

From arrival in operating room until the patients leave post anesthesia care unit

Outcome measures

Measure	Control n=541 Participants 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.	Unanticipated Bleeding n=35 Participants 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.	No Significant Bleeding n=863 Participants Patients in whom surgery did not resulted in significant bleeding
Unanticipated Bleeding	0 percentage of participants	100 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: one day

transfusion pattern in the whole cohort

Outcome measures

Measure	Control n=541 Participants 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.	Unanticipated Bleeding n=35 Participants 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.	No Significant Bleeding n=863 Participants Patients in whom surgery did not resulted in significant bleeding
Transfusions transfusion of pack red blood cell	33 number of participants	31 number of participants	1 number of participants
Transfusions no transfusion	508 number of participants	4 number of participants	862 number of participants

SECONDARY outcome

Timeframe: one day

proportion of patients with preoperative anemia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one day

lowest peroperative hemoglobin concentration

Outcome measures

Outcome data not reported

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unanticipated Bleeding

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Peroperative Significant Bleeding

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Jean-Luc Hanouz

CHU de Caen

Phone: 2 31 06 47 36

Email: hanouz-jl@chu-caen.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place