Epidemiology of Severe Peroperative Bleeding During Scheduled Surgery

NCT ID: NCT02311309

Last Updated: 2016-04-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1439 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Surgery Blood Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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control

Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration \> 8 g/dL.

Control

Intervention Type OTHER

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

Intervention Type OTHER

Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration \< 8 g/dL.

Interventions

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Control

Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration \>8 g/dL.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient scheduled for non cardiac and non emergency surgery

Exclusion Criteria

* Cardiac surgery
* Emergency surgery
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Luc Hanouz, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Other Identifiers

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A13-D48-VOL.19

Identifier Type: -

Identifier Source: org_study_id

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