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Epidemiology of Severe Peroperative Bleeding During Scheduled Surgery

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ClinicalTrials.gov Identifier: NCT02311309
Recruitment Status : Completed
First Posted : December 8, 2014
Results First Posted : April 21, 2016
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Surgery Blood Loss 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.


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Study Type : Observational
Actual Enrollment : 1439 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology of Peroperative Bleeding and Transfusion During Scheduled Surgery.
Study Start Date : November 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Unanticipated Bleeding [ Time Frame: one day ]
    From arrival in operating room until the patients leave post anesthesia care unit


Secondary Outcome Measures :
  1. Transfusions [ Time Frame: one day ]
    transfusion pattern in the whole cohort

  2. Preoperative Anemia [ Time Frame: one day ]
    proportion of patients with preoperative anemia

  3. Lowest Hemoglobin [ Time Frame: one day ]
    lowest peroperative hemoglobin concentration



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients scheduled for surgery (expect cardiac, pediatric, and emergency surgery)
Criteria

Inclusion Criteria:

  • Patient scheduled for non cardiac and non emergency surgery

Exclusion Criteria:

  • Cardiac surgery
  • Emergency surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311309


Sponsors and Collaborators
University Hospital, Caen
Investigators
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Principal Investigator: Jean-Luc Hanouz, M.D.,Ph.D. University Hospital, Caen

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02311309     History of Changes
Other Study ID Numbers: A13-D48-VOL.19
First Posted: December 8, 2014    Key Record Dates
Results First Posted: April 21, 2016
Last Update Posted: April 21, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes