Epidemiology of Severe Peroperative Bleeding During Scheduled Surgery
Epidemiology of Peroperative Bleeding and Transfusion During Scheduled Surgery.
1 other identifier
observational
1,439
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2013
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 4, 2014
CompletedFirst Posted
Study publicly available on registry
December 8, 2014
CompletedResults Posted
Study results publicly available
April 21, 2016
CompletedApril 21, 2016
March 1, 2016
4 months
December 4, 2014
February 9, 2016
March 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Unanticipated Bleeding
From arrival in operating room until the patients leave post anesthesia care unit
one day
Secondary Outcomes (3)
Transfusions
one day
Preoperative Anemia
one day
Lowest Hemoglobin
one day
Study Arms (2)
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.
Interventions
Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration \>8 g/dL.
Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration \< 8 g/dL.
Eligibility Criteria
Consecutive patients scheduled for surgery (expect cardiac, pediatric, and emergency surgery)
You may qualify if:
- Patient scheduled for non cardiac and non emergency surgery
You may not qualify if:
- Cardiac surgery
- Emergency surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Jean-Luc Hanouz
- Organization
- CHU de Caen
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Luc Hanouz, M.D.,Ph.D.
University Hospital, Caen
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2014
First Posted
December 8, 2014
Study Start
November 1, 2013
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
April 21, 2016
Results First Posted
April 21, 2016
Record last verified: 2016-03