Gelatines in Pediatric PatientS (GPS)

B. Braun

Status: Completed

Conditions: Treatment of Hypovolemia and Shock

Treatments: Drug: Gelofusine 4%; Drug: Gelaspan 4%

Study type: Observational

Funder types: Industry

Identifiers

NCT02495285

HC-O-H-1406

Details and patient eligibility

About

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.

Enrollment: 601 patients

Sex: All

Ages: Under 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

601 participants in 2 patient groups

Gelofusine 4%

Description:

Children age ≤ 12 years

Treatment:

Drug: Gelofusine 4%

Gelaspan 4%

Description:

Children age ≤ 12 years

Treatment:

Drug: Gelaspan 4%