Study of Current Standard of Care in the U.S.: Incidence of postoperative events and associated costs among non-cardiac surgery patients exposed to neuromuscular blocking agents in the Cleveland Clinic (2005-2013)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/22856
• EU PAS number:
  EUPAS6435
• Study ID:
  22856
• Official title and acronym:
  Study of Current Standard of Care in the U.S.: Incidence of postoperative events and associated costs among non-cardiac surgery patients exposed to neuromuscular blocking agents in the Cleveland Clinic (2005-2013)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study will provide information on the current burden of unmet needs, healthcare resource utilization and costs for patients exposed to neuromuscular blocking agents (NMBAs). The primary goal of the study is to understand in the population receiving NMBAs the demographic, past medical history and operative characteristics of patients who have postoperative complications and to assess their incidence as well as healthcare resource utilization and costs associated with these complications.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Study timelines

Date when funding contract was signed

Actual: 19/03/2014

Study start date

Planned: 01/06/2014

Actual: 01/07/2014

Data analysis start date

Planned: 28/02/2017

Actual: 28/02/2017

Date of final study report

Planned: 31/07/2017

Actual: 22/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Corp.

Regulatory

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