Epidemiology of Severe Peroperative Bleeding During Scheduled Surgery

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Blood Loss
• Intervention / Treatment: Other: Control; Other: Unanticipated bleeding

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 Type: Observational
• Enrollment (Actual): 1439

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive patients scheduled for surgery (expect cardiac, pediatric, and emergency surgery)

Description

Inclusion Criteria:

• Patient scheduled for non cardiac and non emergency surgery

Exclusion Criteria:

• Cardiac surgery
• Emergency surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control; Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.	Other: 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.	Other: Unanticipated bleeding; Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unanticipated Bleeding	From arrival in operating room until the patients leave post anesthesia care unit	one day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: December 4, 2014
• First Submitted That Met QC Criteria: December 5, 2014
• First Posted (Estimate): December 8, 2014

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: March 22, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: A13-D48-VOL.19