Trial · NCT02495285

Gelatines in Pediatric PatientS

NCT02495285, Completed, B. Braun Melsungen AG; results first posted 2024-12-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Gelatines in Pediatric PatientS. Trials, record NCT02495285. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02495285

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Gelatines in Pediatric PatientS
NCT number: NCT02495285
Status: Completed
Enrollment: 601 participants, actual
Lead sponsor: B. Braun Melsungen AG
Conditions: Treatment of Hypovolemia and Shock
Interventions: Gelofusine 4%, Gelaspan 4%
First posted: 2015-07-13
Last updated: 2024-12-04
Results first posted: 2024-12-04

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Dosing of the Products During Surgery	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Secondary	Potentia Hydrogenii	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.
Secondary	Hemoglobin	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	mmol/L
Secondary	Lactate	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	mmol/l
Secondary	Hematocrit	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	%
Secondary	Glucose	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	mmol/l
Secondary	Serum Prolin	Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions	µmol/l
Secondary	Serum Creatinine	Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions	µmol/l
Secondary	Number of Participants With (Serious) Adverse Events / Reactions	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Secondary	Heart Rate	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	beats per minute

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Dosing of the Products During Surgery	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions		ml/kg	MEAN
SECONDARY	Potentia Hydrogenii	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	The data for potentia hydrogenii were not entered for all partipants by the sites in the data collection form.	unitless	MEAN
SECONDARY	Hemoglobin	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	The data for Hemoglobin were not entered for all participants by the sites in the data collection form.	mmol/L	MEAN
SECONDARY	Lactate	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	The data for lactates were not entered for all participants by the sites in the data collection form.	mmol/l	MEAN
SECONDARY	Hematocrit	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	The data for Hematocrit were not entered for all subjects by the sites in the data collection form.	%	MEAN
SECONDARY	Glucose	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	The data for glucose were not entered for all participants by the sites in the data collection form	mmol/l	MEAN
SECONDARY	Serum Prolin	Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions	Serum proline was only documented in four study participants in total. Not part of clinical routine.	µmol/l	MEAN
SECONDARY	Serum Creatinine	Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions	The data for Serum Creatinine were not entered for all participants by the sites in the data collection form.	µmol/l	MEAN
SECONDARY	Number of Participants With (Serious) Adverse Events / Reactions	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Heart Rate	Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	The data for heart rate were not entered for all participants by the sites in the data collection form.	beats per minute	MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Dosing of the Products During Surgery	Gelofusine 4%		14.58	Standard Deviation 6.85	ml/kg
Dosing of the Products During Surgery	Gelaspan 4%		12.64	Standard Deviation 4.72	ml/kg
Potentia Hydrogenii	Gelofusine 4%	Before Infusion	7.35	Standard Deviation 0.08	unitless
Potentia Hydrogenii	Gelaspan 4%	Before Infusion	7.34	Standard Deviation 0.06	unitless
Potentia Hydrogenii	Gelofusine 4%	After Infusion	7.34	Standard Deviation 0.07	unitless
Potentia Hydrogenii	Gelaspan 4%	After Infusion	7.32	Standard Deviation 0.07	unitless
Hemoglobin	Gelofusine 4%	Before Infusion	11.02	Standard Deviation 2.51	mmol/L
Hemoglobin	Gelaspan 4%	Before Infusion	11.35	Standard Deviation 2.22	mmol/L
Hemoglobin	Gelofusine 4%	After infusion	10.01	Standard Deviation 2.42	mmol/L
Hemoglobin	Gelaspan 4%	After infusion	10.30	Standard Deviation 2.16	mmol/L

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Gelofusine 4%	121
Overall Study	STARTED	Gelaspan 4%	480
Overall Study	COMPLETED	Gelofusine 4%	121
Overall Study	COMPLETED	Gelaspan 4%	480
Overall Study	NOT COMPLETED	Gelofusine 4%	0
Overall Study	NOT COMPLETED	Gelaspan 4%	0

Source ClinicalTrials.gov

Adverse events10

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Procedural nausea	Injury, poisoning and procedural complications	Gelofusine 4%	1	121	1
other	Procedural nausea	Injury, poisoning and procedural complications	Gelaspan 4%	0	480	0
other	Haemorrhage	Vascular disorders	Gelofusine 4%	1	121	1
other	Haemorrhage	Vascular disorders	Gelaspan 4%	1	480	1
other	Electrolyte imblance	Metabolism and nutrition disorders	Gelofusine 4%	0	121	0
other	Electrolyte imblance	Metabolism and nutrition disorders	Gelaspan 4%	1	480	1
other	Hemodilution	Injury, poisoning and procedural complications	Gelofusine 4%	0	121	0
other	Hemodilution	Injury, poisoning and procedural complications	Gelaspan 4%	1	480	1
serious	Procedural hemorrhage	Injury, poisoning and procedural complications	Gelofusine 4%	0	121	0
serious	Procedural hemorrhage	Injury, poisoning and procedural complications	Gelaspan 4%	1	480	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gelofusine 4%	0	121
Total, all-cause mortality	Gelaspan 4%	0	480
Total, other adverse events	Gelofusine 4%	1	121
Total, other adverse events	Gelaspan 4%	3	480
Total, serious adverse events	Gelofusine 4%	0	121
Total, serious adverse events	Gelaspan 4%	1	480

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35588274	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Gelofusine 4% vs Gelaspan 4%: Number of Participants With (Serious) Adverse Events / Reactions	Trial comparisons
Gelofusine 4% vs Gelaspan 4%: Follow-up Assessed by Number of Participants With Post-operative Complications	Trial comparisons
Gelofusine 4% vs Gelaspan 4%: deaths from any cause	Trial comparisons
Gelofusine 4% vs Gelaspan 4%: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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