Gelatines in Pediatric PatientS

• Status: Completed
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: B. Braun Melsungen AG
• Treatments: Polygeline

Criteria

Inclusion:

• Age ≤ 12 years

• American Society of Anesthesiologists (ASA) risk score: ≤ III

• Peri-operative infusion of gelatine solutions

• Informed consent and/or data protection declaration signed by parents/legal guardians (according to local requirements)

Exclusion:

• Inclusion in another investigational study in the field of volume replacement which could interfere with the routine clinical practice regarding the administration of the gelatine solutions

• In addition contraindications as outlined in the valid local Summaries of Product Characteristics (SmPCs) have to be considered.