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Gelatines in Pediatric PatientS

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02495285
Acronym
GPS
Enrollment
601
Registered
2015-07-13
Start date
2015-05-31
Completion date
2020-05-31
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of Hypovolemia and Shock

Keywords

pediatric patients gelatine

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.

Interventions

DRUGGelofusine 4%
DRUGGelaspan 4%

Sponsors

B. Braun Melsungen AG
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 12 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frame
Dosing of the Products During SurgeryBefore (0 - 2 h) and up to 2 h after infusion of gelatin solutions

Secondary

MeasureTime frameDescription
Number of Participants With (Serious) Adverse Events / ReactionsBefore (0 - 2 h) and up to 2 h after infusion of gelatin solutions—
Heart RateBefore (0 - 2 h) and up to 2 h after infusion of gelatin solutionsbeats per minute
Mean Arterial PressureBefore (0 - 2 h) and up to 2 h after infusion of gelatin solutionsmmHg
Potentia HydrogeniiBefore (0 - 2 h) and up to 2 h after infusion of gelatin solutionsPotentia hydrogenii (ph) was part of blood sampling/laboratory to measure the levels of oxygen and carbon dioxide.
HemoglobinBefore (0 - 2 h) and up to 2 h after infusion of gelatin solutionsmmol/L
Follow-up Assessed by Number of Participants With Post-operative ComplicationsAt discharge from the hospital or in-hospital 3 months after start of gelatine infusion, whatever occurs first.—
HematocritBefore (0 - 2 h) and up to 2 h after infusion of gelatin solutions%
GlucoseBefore (0 - 2 h) and up to 2 h after infusion of gelatin solutionsmmol/l
Serum ProlinBefore (0 - 2 days) and up to 2 days after infusion of gelatin solutionsµmol/l
Serum CreatinineBefore (0 - 2 days) and up to 2 days after infusion of gelatin solutionsµmol/l
LactateBefore (0 - 2 h) and up to 2 h after infusion of gelatin solutionsmmol/l

Countries

Bulgaria, Germany, Italy, Spain, United Kingdom

Participant flow

Pre-assignment details

Enrolment target of 1500 patients was not met due to slow recruitment although duration of study had been extended to 60 months

Participants by arm

ArmCount
Gelofusine 4%
Children age ≤ 12 years Gelofusine 4%
121
Gelaspan 4%
Children age ≤ 12 years Gelaspan 4%
480
Total601

Baseline characteristics

CharacteristicGelofusine 4%Gelaspan 4%Total
Age, Categorical
<=18 years
121 Participants480 Participants601 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous52.6 months
STANDARD_DEVIATION 45.7
23.15 months
STANDARD_DEVIATION 34.12
29.08 months
STANDARD_DEVIATION 38.55
Race and Ethnicity Not Collected——0 Participants
Region of Enrollment
Bulgaria
30 participants0 participants30 participants
Region of Enrollment
Germany
20 participants431 participants451 participants
Region of Enrollment
Italy
53 participants6 participants59 participants
Region of Enrollment
Spain
10 participants43 participants53 participants
Region of Enrollment
United Kingdom
8 participants0 participants8 participants
Sex: Female, Male
Female
46 Participants203 Participants249 Participants
Sex: Female, Male
Male
75 Participants277 Participants352 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1210 / 480
other
Total, other adverse events
1 / 1213 / 480
serious
Total, serious adverse events
0 / 1211 / 480

Outcome results

Primary

Dosing of the Products During Surgery

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

ArmMeasureValue (MEAN)Dispersion
Gelofusine 4%Dosing of the Products During Surgery14.58 ml/kgStandard Deviation 6.85
Gelaspan 4%Dosing of the Products During Surgery12.64 ml/kgStandard Deviation 4.72
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Gelofusine 4%Follow-up Assessed by Number of Participants With Post-operative Complications0 Participants
Gelaspan 4%Follow-up Assessed by Number of Participants With Post-operative Complications4 Participants
Secondary

Glucose

mmol/l

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

Population: The data for glucose were not entered for all participants by the sites in the data collection form

ArmMeasureGroupValue (MEAN)Dispersion
Gelofusine 4%GlucoseAfter infusion6.83 mmol/lStandard Deviation 4.36
Gelofusine 4%GlucoseBefore infusion6.13 mmol/lStandard Deviation 3.02
Gelaspan 4%GlucoseAfter infusion6.61 mmol/lStandard Deviation 1.96
Gelaspan 4%GlucoseBefore infusion5.21 mmol/lStandard Deviation 1.18
Secondary

Heart Rate

beats per minute

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

Population: The data for heart rate were not entered for all participants by the sites in the data collection form.

ArmMeasureGroupValue (MEAN)Dispersion
Gelofusine 4%Heart RateBefore infusion116.74 beats per minuteStandard Deviation 25.72
Gelofusine 4%Heart RateAfter infusion113.24 beats per minuteStandard Deviation 22.54
Gelaspan 4%Heart RateBefore infusion121.20 beats per minuteStandard Deviation 22.54
Gelaspan 4%Heart RateAfter infusion118.72 beats per minuteStandard Deviation 21.88
Secondary

Hematocrit

%

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

Population: The data for Hematocrit were not entered for all subjects by the sites in the data collection form.

ArmMeasureGroupValue (MEAN)Dispersion
Gelofusine 4%HematocritBefore infusion35.33 %Standard Error 6.76
Gelofusine 4%HematocritAfter infusion31.67 %Standard Error 7.64
Gelaspan 4%HematocritBefore infusion35.06 %Standard Error 6.92
Gelaspan 4%HematocritAfter infusion32.07 %Standard Error 7.12
Secondary

Hemoglobin

mmol/L

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

Population: The data for Hemoglobin were not entered for all participants by the sites in the data collection form.

ArmMeasureGroupValue (MEAN)Dispersion
Gelofusine 4%HemoglobinBefore Infusion11.02 mmol/LStandard Deviation 2.51
Gelofusine 4%HemoglobinAfter infusion10.01 mmol/LStandard Deviation 2.42
Gelaspan 4%HemoglobinBefore Infusion11.35 mmol/LStandard Deviation 2.22
Gelaspan 4%HemoglobinAfter infusion10.30 mmol/LStandard Deviation 2.16
Secondary

Lactate

mmol/l

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

Population: The data for lactates were not entered for all participants by the sites in the data collection form.

ArmMeasureGroupValue (MEAN)Dispersion
Gelofusine 4%LactateBefore infusion1.38 mmol/lStandard Deviation 0.8
Gelofusine 4%LactateAfter infusion1.48 mmol/lStandard Deviation 0.87
Gelaspan 4%LactateBefore infusion1.19 mmol/lStandard Deviation 0.62
Gelaspan 4%LactateAfter infusion1.30 mmol/lStandard Deviation 0.82
Secondary

Mean Arterial Pressure

mmHg

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

Population: The data for mean arterial pressure were not entered for all participants by the sites in the data collection form

ArmMeasureGroupValue (MEAN)Dispersion
Gelofusine 4%Mean Arterial PressureBefore infusion58.03 mmHgStandard Deviation 14.81
Gelofusine 4%Mean Arterial PressureAfter infusion65.23 mmHgStandard Deviation 14.48
Gelaspan 4%Mean Arterial PressureBefore infusion46.72 mmHgStandard Deviation 11.54
Gelaspan 4%Mean Arterial PressureAfter infusion55.55 mmHgStandard Deviation 11.25
Secondary

Number of Participants With (Serious) Adverse Events / Reactions

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Gelofusine 4%Number of Participants With (Serious) Adverse Events / Reactions1 Participants
Gelaspan 4%Number of Participants With (Serious) Adverse Events / Reactions4 Participants
Secondary

Potentia Hydrogenii

Potentia hydrogenii (ph) was part of blood sampling/laboratory to measure the levels of oxygen and carbon dioxide.

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

Population: The data for potentia hydrogenii were not entered for all partipants by the sites in the data collection form.

ArmMeasureGroupValue (MEAN)Dispersion
Gelofusine 4%Potentia HydrogeniiBefore Infusion7.35 unitlessStandard Deviation 0.08
Gelofusine 4%Potentia HydrogeniiAfter Infusion7.34 unitlessStandard Deviation 0.07
Gelaspan 4%Potentia HydrogeniiBefore Infusion7.34 unitlessStandard Deviation 0.06
Gelaspan 4%Potentia HydrogeniiAfter Infusion7.32 unitlessStandard Deviation 0.07
Secondary

Serum Creatinine

µmol/l

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

Population: The data for Serum Creatinine were not entered for all participants by the sites in the data collection form.

ArmMeasureGroupValue (MEAN)Dispersion
Gelofusine 4%Serum CreatinineBefore infusion30.92 µmol/lStandard Deviation 15.32
Gelofusine 4%Serum CreatinineAfter infusion30.23 µmol/lStandard Deviation 14.06
Gelaspan 4%Serum CreatinineBefore infusion31.08 µmol/lStandard Deviation 16.48
Gelaspan 4%Serum CreatinineAfter infusion33.13 µmol/lStandard Deviation 17.8
Secondary

Serum Prolin

µmol/l

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

Population: Serum proline was only documented in four study participants in total. Not part of clinical routine.

ArmMeasureGroupValue (MEAN)Dispersion
Gelofusine 4%Serum ProlinBefore infusion235.25 µmol/lStandard Deviation 2.5
Gelofusine 4%Serum ProlinAfter infusion180 µmol/lStandard Deviation 43.63

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026