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Clinical Trials/NCT02495285
NCT02495285CompletedNot Applicable

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

B. Braun Melsungen AG11 sites in 5 countries601 target enrollmentStarted: May 2015Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
601
Locations
11
Primary Endpoint
Dosing of the Products During Surgery
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Gelofusine 4%

Children age ≤ 12 years

Intervention: Gelofusine 4% (Drug)

Gelaspan 4%

Children age ≤ 12 years

Intervention: Gelaspan 4% (Drug)

Outcomes

Primary Outcomes

Dosing of the Products During Surgery

Time Frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

Secondary Outcomes

  • Potentia Hydrogenii(Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions)
  • Hemoglobin(Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions)
  • Lactate(Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions)
  • Hematocrit(Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions)
  • Glucose(Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions)
  • Serum Prolin(Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions)
  • Serum Creatinine(Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions)
  • Number of Participants With (Serious) Adverse Events / Reactions(Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions)
  • Heart Rate(Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions)
  • Mean Arterial Pressure(Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions)
  • Follow-up Assessed by Number of Participants With Post-operative Complications(At discharge from the hospital or in-hospital 3 months after start of gelatine infusion, whatever occurs first.)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (11)

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