Trials / Completed
CompletedNCT03338218
Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients
Pragmatic, Prospective, Randomized, Controlled, Double-blind, Multi-centre, Multinational Study on the Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 238 (actual)
- Sponsor
- Fresenius Kabi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the study is to investigate the safety of a 6% hydroxyethyl starch (HES) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in trauma patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Volulyte 6% | Solution for infusion |
| DRUG | Ionolyte | Solution for infusion |
Timeline
- Start date
- 2019-02-23
- Primary completion
- 2022-06-25
- Completion
- 2022-06-25
- First posted
- 2017-11-09
- Last updated
- 2022-08-05
Locations
22 sites across 7 countries: Belgium, Czechia, France, Germany, Netherlands, South Africa, Spain
Source: ClinicalTrials.gov record NCT03338218. Inclusion in this directory is not an endorsement.