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Gelatines in Pediatric PatientS

NCT02495285 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 601

Last updated 2024-12-04

Study results available
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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

  • Treatment of Hypovolemia and Shock

Interventions

DRUG

Gelofusine 4%

DRUG

Gelaspan 4%

Sponsors & Collaborators

  • B. Braun Melsungen AG

    lead INDUSTRY

Principal Investigators

  • Robert Sümpelmann, Prof. · Medizinische Hochschule Hannover (MHH)

Eligibility

Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • Bulgaria
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02495285 on ClinicalTrials.gov