drugset / Trial / NCT03338218
Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients
Phase 4
Completed
238 enrolled
Fresenius Kabi
B. Braun Melsungen AG · collabEuropean Society of Anaesthesiology and Intensive Care · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2019-02-23
- Primary completion
- 2022-06-25
- Completion
- 2022-06-25
Publications
- Palma CD, Mamba M, Geldenhuys J, Fadahun O, Rossaint R, Zacharowski K, Brand M, Diaz-Cambronero O, Belda J, Westphal M, Brauer U, Dormann D, Dehnhardt T, Hernandez-Gonzalez M, Schmier S, de Korte D, Plani F, Buhre W. 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: study protocol for the TETHYS study. Trials. 2022 Jun 2;23(1):456. doi: 10.1186/s13063-022-06390-x.
- Chappell D, Jacob M. Should hydroxyethyl starch be banned? Lancet. 2018 Jul 14;392(10142):118. doi: 10.1016/S0140-6736(18)31174-7. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ionolyte | Other / unclassified | — | Intravenous |
| Subject | Volulyte | Other / unclassified | — | Intravenous |