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

Study identification

• EU PAS number:
  EUPAS8398
• Study ID:
  17958
• Official title and acronym:
  Binocrit® in the management of preoperative anemia in patients scheduled to undergo major elective orthopedic surgery - a Prospective Observational Study (BONES)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The BONES study is a National Multicenter Prospective Observational Study.Preoperative anemia in elective orthopedic surgery has been associated with increased mortality and morbidity after surgery, increased blood transfusion therapy and rates of postoperative infection leading to a longer duration of hospital stay 1. The patient hemoglobin level (Hb) before elective surgery should be within the normal range. Epoetin alfa has been shown to safely increase preoperative Hb levels in anemic patients undergoing elective noncardiac, nonvascular surgery and is more effective than preoperative autologous blood donation in reducing the need for perioperative blood transfusions in orthopedic surgery patients 2. The aim of this study is to describe Binocrit® (epoetin alfa) modalities of use and its impact on preoperative anemia evolution in patients scheduled to undergo a major elective orthopedic surgery.Pre-defined investigations or tests, which were completed as routine practice and recorded in the patient chart will be collected pertaining to: demographics and baseline patient's characteristics, medical history, clinical evaluation, Binocrit® prescription and administration, key laboratory parameters, concomitant medications, blood saving strategy, major elective orthopedic surgery features, hospitalization duration and potential complication, adverse events.All data collected will be anonymized thus protecting patient's identities.No interventional procedures or change to current medical practice are required.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Sandoz

Study timelines

Date when funding contract was signed

Planned:28/08/2014

Actual:28/08/2014

Study start date

Planned:16/03/2015

Actual:27/03/2015

Date of final study report

Planned:31/03/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

SANDOZ

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable