Trials / Completed
CompletedNCT02495285
Gelatines in Pediatric PatientS
Infusion of Gelatine Solutions in Pediatric Patients Aged up to 12 Years
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 601 (actual)
- Sponsor
- B. Braun Melsungen AG · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gelofusine 4% | |
| DRUG | Gelaspan 4% |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2020-05-01
- Completion
- 2020-05-01
- First posted
- 2015-07-13
- Last updated
- 2024-12-04
- Results posted
- 2024-12-04
Locations
11 sites across 5 countries: Bulgaria, Germany, Italy, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02495285. Inclusion in this directory is not an endorsement.