Epidemiology of Severe Peroperative Bleeding During Scheduled Surgery

Completed

• Conditions: Blood Loss; Surgery
• Interventions: Other: Control; Other: Unanticipated bleeding

• Registration Number: NCT02311309
• Lead Sponsor: University Hospital, Caen

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.

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Study First Submitted: 2014-12-04
• Study First Submitted QC: 2014-12-05
• Study First Posted: 2014-12-08
• Results First Submitted: 2016-02-09
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-22
• Last Update Submitted: 2016-03-22
• Results First Posted: 2016-04-21
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1439

Inclusion Criteria

• Patient scheduled for non cardiac and non emergency surgery

Exclusion Criteria

• Cardiac surgery
• Emergency surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control	Control	Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration \> 8 g/dL.
unanticipated bleeding	Unanticipated bleeding	Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration \< 8 g/dL.

Primary Outcome Measures

Name	Time	Method
Unanticipated Bleeding	one day	From arrival in operating room until the patients leave post anesthesia care unit

Secondary Outcome Measures

Name	Time	Method
Transfusions	one day	transfusion pattern in the whole cohort
Preoperative Anemia	one day	proportion of patients with preoperative anemia
Lowest Hemoglobin	one day	lowest peroperative hemoglobin concentration