CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 601 enrolled
Drug / intervention
Gelofusine 4% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02495285
NCT02495285N/ACompleted

Infusion of Gelatine Solutions in Pediatric Patients Aged up to 12 Years

B. Braun Melsungen AG·observational·Posted Jul 13, 2015·Updated Dec 4, 2024

In Brief

An observational study evaluating Gelofusine 4% and Gelaspan 4% for Treatment of Hypovolemia and Shock. Completed, enrolled 601 participants across 11 sites in 5 countries.

Detailed Summary

The aim of volume replacement is to compensate a reduction in the intravascular volume e.g. during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital functions. So far, there is only few data on the safety and efficacy of the products under investigation in children. The primary aim of this non-interventional observational study (NIS) is to collect further data of gelatine solutions in a large pediatric population during routine clinical practice.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Germany, Italy, Spain, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 13, 2015
Enrollment StartMay 1, 2015
Primary CompletionMay 1, 2020
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 11.0 years ago

Interventions

Gelofusine 4%drug

Gelaspan 4%drug