Hydroxyethyl starch (HES) solutions and risk of acute kidney injury and mortality in acute trauma patients

Study identification

• EU PAS number:
  EUPAS31996
• Study ID:
  31997
• Official title and acronym:
  Hydroxyethyl starch (HES) solutions and risk of acute kidney injury and mortality in acute trauma patients
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A systematic review of the literature was performed, to update the previously systematized evidence in 2013, regarding the risk of using HES in trauma patients. Only the new evidence occurred since the last referral (when all available evidence was thoroughly reviewed) was considered (01/08/2013 - 22/11/2017).
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned:01/09/2017

Actual:01/09/2017

Study start date

Planned:15/09/2017

Actual:15/09/2017

Data analysis start date

Planned:01/11/2017

Actual:01/11/2017

Date of final study report

Planned:27/11/2017

Actual:27/11/2017

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable