Gelatines in Pediatric PatientS (GPS)

October 15, 2024 updated by: B. Braun Melsungen AG

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
601

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1606
        • National Cardiology Hospital
  • Germany
      • Hannover, Germany, 30173
        • Auf der Bult
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin
      • Nuernberg, Germany, 90419
        • Klinik Hallerwiese/Cnopf´sche Kinderklinik
      • Stuttgart, Germany, 70174
        • Klinikum Stuttgart, Olgahospital und Frauenklinik
  • Italy
      • Catania, Italy, I-95100
        • Azienda Policlinico Universitaria G. Rodolico -Vittorio Emanuele
      • Milano, Italy, I-20154
        • Ospedale dei Bambini Vittore Buzzi
  • Spain
      • Barcelona, Spain
        • Vall d'Hebron University Hospital
      • Barcelona, Spain
        • Hospital de Sant Joan de Déu
      • Palma De Mallorca, Spain
        • Hospital Son Espases
  • United Kingdom
      • Liverpool, United Kingdom, L12 2AP
        • Alder Hey Children's NHS FT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 12 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

children

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Gelofusine 4%
Children age ≤ 12 years
Drug: Gelofusine 4%
Gelaspan 4%
Children age ≤ 12 years
Drug: Gelaspan 4%

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Dosing of the Products During Surgery
Time Frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Potentia Hydrogenii
Time Frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Potentia hydrogenii (ph) was part of blood sampling/laboratory to measure the levels of oxygen and carbon dioxide.
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Hemoglobin
Time Frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
mmol/L
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Lactate
Time Frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
mmol/l
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Hematocrit
Time Frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
%
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Glucose
Time Frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
mmol/l
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Serum Prolin
Time Frame: Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions
µmol/l
Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions
Serum Creatinine
Time Frame: Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions
µmol/l
Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions
Number of Participants With (Serious) Adverse Events / Reactions
Time Frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Heart Rate
Time Frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
beats per minute
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Mean Arterial Pressure
Time Frame: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
mmHg
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
Time Frame: At discharge from the hospital or in-hospital 3 months after start of gelatine infusion, whatever occurs first.
At discharge from the hospital or in-hospital 3 months after start of gelatine infusion, whatever occurs first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
B. Braun Melsungen AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Sümpelmann, Prof., Medizinische Hochschule Hannover (MHH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HC-O-H-1406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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