Medical Need of Non-vitamin K Oral Anti-coagulant Reversal in Japan: Epidemiological Assessment of Emergency Surgery, Trauma and Fracture, using Large Scale Claims Database

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20054
• EU PAS number:
  EUPAS20053
• Study ID:
  20054
• Official title and acronym:
  Medical Need of Non-vitamin K Oral Anti-coagulant Reversal in Japan: Epidemiological Assessment of Emergency Surgery, Trauma and Fracture, using Large Scale Claims Database
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The primary objective of this study is to assess the incidence rates of emergency surgery and major bleeding associated with fracture and trauma. Secondary objective is to assess the incidence rates of cardiac tamponade and pericardiocentesis.A further objective is to describe the types of emergency surgeries identified
• Study status:
  Planned

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned: 17/08/2017

Study start date

Planned: 28/07/2017

Date of final study report

Planned: 29/09/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Nippon Boehringer Ingelheim

Study protocol

Initial protocol

20170714_PROTOCOL-Trauma_Surgery final_edit

Regulatory

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