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HES vs Lactated Ringer's in SAH
NCT02064075Phase 4
Key facts
- Status
- Completed
- Start
- Feb 2013
- Primary completion
- Oct 2013
- Countries
- 1
- Sponsor
- University of Debrecen
- Modality
- Polymer-based Nanoparticles, Lipid-based Nanoparticles, Small Molecules
- Drugs
- hetastarch
- Conditions
- subarachnoid hemorrhage (SAH)
01
Overview
Phase 4, randomised, double-blind trial of hetastarch in subarachnoid hemorrhage (SAH) (2 arms), sponsored by University of Debrecen. Primary endpoint: Incidence of vasospasm at 14 days. Started Feb 2013; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Hydroxyethyl starch Group
15 ml/kg Lactated-Ringer's + 15-50 ml/kg Hydroxyethyl starch daily
Lactated Ringer's Group
15-50 ml/kg Lactated-Ringer's solution daily
03
Who it enrols
Patients with subarachnoid hemorrhage and Hunt-Hess grade I-III.
04
Endpoints
Primary
Incidence of vasospasm
Secondary
30-day survival
Glasgow Outcome Scale
Barthel Index of Activities of Daily Living
National Institutes of Health Stroke Scale
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