A Multicenter, Non-interventional, Observational, Post-Approval Safety Study of Updated ACCUSOL 35 Solutions in Continuous Renal Replacement Therapy (ACCUPASS)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS6800
• Study ID:
  29084
• Official title and acronym:
  A Multicenter, Non-interventional, Observational, Post-Approval Safety Study of Updated ACCUSOL 35 Solutions in Continuous Renal Replacement Therapy (ACCUPASS)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This is a multicenter, non-interventional, single-arm, observational, post-approval safety study in adult patients undergoing CRRT using any ACCUSOL 35 solution(s). The primary endpoint is the presence or absence of visible precipitate in the CRRT lines used during the study.
• Study status:
  Finalised

Research institutions and networks

Institutions

Baxter Healthcare Corporation

Multiple centres: 17 centers are involved in the study

Study timelines

Date when funding contract was signed

Planned:27/06/2014

Actual:27/06/2014

Study start date

Planned:01/10/2014

Actual:19/03/2015

Date of final study report

Planned:30/08/2016

Actual:30/09/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Baxter Healthcare Corporation

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)