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Completed

NCT Number: NCT02311309

Epidemiology of Severe Peroperative Bleeding 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.

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Key information

Conditions

Surgery Blood Loss Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient scheduled for non cardiac and non emergency surgery

Exclusion criteria

  • Cardiac surgery
  • Emergency surgery

Treatment and study plan

Control

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

Other

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

Primary outcomes

  1. Unanticipated Bleeding

    Time frame: one day

    From arrival in operating room until the patients leave post anesthesia care unit

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

Epidemiology of Peroperative Bleeding and Transfusion During Scheduled Surgery.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 8, 2014
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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