Binocrit® in the management of preoperative anemia in patients scheduled to undergo major elective orthopedic surgery - a Prospective Observational Study (BONES)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Anaemia prophylaxis

  Orthopaedic procedure

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  Describe the evolution of hemoglobin and hematocrit (Ht) preoperative levels after Binocrit® treatment in patients scheduled to undergo a major elective orthopedic surgery.
• Outcomes:
  Percentage of patients achieving an Hb level > 13g/dL and/or a Ht level > 40% at the preoperative visit performed the day before or the day of the major elective orthopedic surgery. Description of patient’s characteristicsDescription of Binocrit® modalities of use and its compliance with SmPCDescription of patients requiring blood cell transfusion per and post-surgeryEvaluation of compliance with the NATA guidelines 3 and French transfusion recommendationsDescription of hospitalization duration and postoperative complicationsDescription of Binocrit® safety
• Data analysis plan:
  The main parameter to estimate is the percentage of patients presenting an Hb level ≥ 13g/ dL and/or an Ht rate> 40% during the preoperative period. This percentage will be evaluated with the bilateral confidence interval of 95% associated. For this parameter a multivariate logistic model will be considered with Odds ratios and associated confidence intervals of 95%. The kinetics of evolution since the anesthesia consultation (study entry, V1) to the preoperative visit (V2) will be described using a linear mixed-effects model including all data related to hemoglobin during this time range regardless of the number of entries per patient. This model considers the hemoglobin slope during this period. The same model will be used for hematocrit. A scatter plot of hemoglobin (x-axis the number of days before surgery, y-axis the value of hemoglobin) will be drawn. In these models, identified variables of the logistic model could be tested in a covariance analysis.