Epidemiology of Severe Peroperative Bleeding During Scheduled Surgery

Surgery Clinical Trial

Official title:

Epidemiology of Peroperative Bleeding and Transfusion During Scheduled Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02311309
• Other study ID #: A13-D48-VOL.19
• Status: Completed
• Phase: N/A
• First received: December 4, 2014
• Last updated: December 19, 2014
• Start date: November 2013
• Est. completion date: March 2014

Study information

• Verified date: December 2014
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1439
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Patient scheduled for non cardiac and non emergency surgery

Exclusion Criteria:

• Cardiac surgery

• Emergency surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Loss
• Surgery

Intervention

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 peroperative hemoglobin concentration < 8 g/dL.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	unanticipated bleeding	From arrival in operating room until the patients leave post anesthesia care unit	one day	No
Secondary	transfusions	transfusion pattern in the whole cohort	one day	No
Secondary	preoperative anemia	proportion of patients with preoperative anemia	one day	No
Secondary	lowest hemoglobin	lowest peroperative hemoglobin concentration	one day	No