WHO ICTRP trial
Controlled, international study conducted in several centres on the therapeutic…
EUCTR2015-000057-20-HU · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2015-000057-20-HU |
|---|---|
| Public title | Controlled, international study conducted in several centres on the therapeutic effect and safety of an early controlled plasma volume replacement treatment with a balanced gelatin solution tested against a balanced salt solution in patients with severe septis / septic shock |
| Scientific title | PROSPECTIVE, RANDOMIZED, CONTROLLED, DOUBLE-BLIND, MULTI-CENTRIC, INTERNATIONAL, STUDY ON THE EFFICACY AND SAFETY OF AN EARLY TARGET CONTROLLED PLASMA VOLUME REPLACEMENT THERAPY WITH A BALANCED GELATIN SOLUTION VS A BALANCED ELECTROLYTE SOLUTION IN PATIENTS WITH SEVERE SEPSIS / SEPTIC SHOCK - GENIUS… |
| Primary sponsor | B. Braun Melsungen AG |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes |
| Countries | Czech Republic;Hungary;Spain;Austria;Germany |
| Conditions | Hypovolaemia in Severe Sepsis / Septic Shock MedDRA version: 18.0 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0 Level: PT Classification code… |
| Interventions | Trade Name: Gelafundin ISO 40 mg/ml Infusionslösung Product Name: Gelaspan Pharmaceutical Form: Solution for infusion CAS Number: 8000049276 Other descriptive name: SUCCINYLATED GELATIN Concentration unit: g/l gram(s)/litre Concentration… |
| Registration date | Jul 27, 2015 |
| Target size | 608 |
| Secondary IDs | HC-G-H-1209 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: