Trial Outcomes & Findings for Gelatines in Pediatric PatientS (NCT NCT02495285)

NCT ID: NCT02495285

Last Updated: 2024-12-04

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 601 participants
• Primary outcome timeframe: Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
• Results posted on: 2024-12-04

Participant Flow

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

Participant milestones

Measure	Gelofusine 4% Children age ≤ 12 years Gelofusine 4%	Gelaspan 4% Children age ≤ 12 years Gelaspan 4%
Overall Study STARTED	121	480
Overall Study COMPLETED	121	480
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Gelofusine 4% n=121 Participants Children age ≤ 12 years Gelofusine 4%	Gelaspan 4% n=480 Participants Children age ≤ 12 years Gelaspan 4%	Total n=601 Participants Total of all reporting groups
Age, Categorical <=18 years	121 Participants n=121 Participants	480 Participants n=480 Participants	601 Participants n=601 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=121 Participants	0 Participants n=480 Participants	0 Participants n=601 Participants
Age, Categorical >=65 years	0 Participants n=121 Participants	0 Participants n=480 Participants	0 Participants n=601 Participants
Age, Continuous	52.6 months STANDARD_DEVIATION 45.70 • n=121 Participants	23.15 months STANDARD_DEVIATION 34.12 • n=480 Participants	29.08 months STANDARD_DEVIATION 38.55 • n=601 Participants
Sex: Female, Male Female	46 Participants n=121 Participants	203 Participants n=480 Participants	249 Participants n=601 Participants
Sex: Female, Male Male	75 Participants n=121 Participants	277 Participants n=480 Participants	352 Participants n=601 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Italy	53 participants n=121 Participants	6 participants n=480 Participants	59 participants n=601 Participants
Region of Enrollment United Kingdom	8 participants n=121 Participants	0 participants n=480 Participants	8 participants n=601 Participants
Region of Enrollment Bulgaria	30 participants n=121 Participants	0 participants n=480 Participants	30 participants n=601 Participants
Region of Enrollment Germany	20 participants n=121 Participants	431 participants n=480 Participants	451 participants n=601 Participants
Region of Enrollment Spain	10 participants n=121 Participants	43 participants n=480 Participants	53 participants n=601 Participants

PRIMARY outcome

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

Outcome measures

Measure	Gelofusine 4% n=121 Participants Children age ≤ 12 years Gelofusine 4%	Gelaspan 4% n=480 Participants Children age ≤ 12 years Gelaspan 4%
Dosing of the Products During Surgery	14.58 ml/kg Standard Deviation 6.85	12.64 ml/kg Standard Deviation 4.72

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Gelofusine 4% n=121 Participants Children age ≤ 12 years Gelofusine 4%	Gelaspan 4% n=480 Participants Children age ≤ 12 years Gelaspan 4%
Potentia Hydrogenii Before Infusion	7.35 unitless Standard Deviation 0.08	7.34 unitless Standard Deviation 0.06
Potentia Hydrogenii After Infusion	7.34 unitless Standard Deviation 0.07	7.32 unitless Standard Deviation 0.07

SECONDARY outcome

Timeframe: 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.

mmol/L

Outcome measures

Measure	Gelofusine 4% n=121 Participants Children age ≤ 12 years Gelofusine 4%	Gelaspan 4% n=480 Participants Children age ≤ 12 years Gelaspan 4%
Hemoglobin Before Infusion	11.02 mmol/L Standard Deviation 2.51	11.35 mmol/L Standard Deviation 2.22
Hemoglobin After infusion	10.01 mmol/L Standard Deviation 2.42	10.30 mmol/L Standard Deviation 2.16

SECONDARY outcome

Timeframe: 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.

mmol/l

Outcome measures

Measure	Gelofusine 4% n=121 Participants Children age ≤ 12 years Gelofusine 4%	Gelaspan 4% n=480 Participants Children age ≤ 12 years Gelaspan 4%
Lactate Before infusion	1.38 mmol/l Standard Deviation 0.80	1.19 mmol/l Standard Deviation 0.62
Lactate After infusion	1.48 mmol/l Standard Deviation 0.87	1.30 mmol/l Standard Deviation 0.82

SECONDARY outcome

Timeframe: 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.

%

Outcome measures

Measure	Gelofusine 4% n=121 Participants Children age ≤ 12 years Gelofusine 4%	Gelaspan 4% n=480 Participants Children age ≤ 12 years Gelaspan 4%
Hematocrit Before infusion	35.33 "%" Standard Error 6.76	35.06 "%" Standard Error 6.92
Hematocrit After infusion	31.67 "%" Standard Error 7.64	32.07 "%" Standard Error 7.12

SECONDARY outcome

Timeframe: 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

mmol/l

Outcome measures

Measure	Gelofusine 4% n=121 Participants Children age ≤ 12 years Gelofusine 4%	Gelaspan 4% n=480 Participants Children age ≤ 12 years Gelaspan 4%
Glucose After infusion	6.83 mmol/l Standard Deviation 4.36	6.61 mmol/l Standard Deviation 1.96
Glucose Before infusion	6.13 mmol/l Standard Deviation 3.02	5.21 mmol/l Standard Deviation 1.18

SECONDARY outcome

Timeframe: 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.

µmol/l

Outcome measures

Measure	Gelofusine 4% n=121 Participants Children age ≤ 12 years Gelofusine 4%	Gelaspan 4% n=480 Participants Children age ≤ 12 years Gelaspan 4%
Serum Prolin Before infusion	235.25 µmol/l Standard Deviation 2.5	—
Serum Prolin After infusion	180 µmol/l Standard Deviation 43.63	—

SECONDARY outcome

Timeframe: 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.

µmol/l

Outcome measures

Measure	Gelofusine 4% n=121 Participants Children age ≤ 12 years Gelofusine 4%	Gelaspan 4% n=480 Participants Children age ≤ 12 years Gelaspan 4%
Serum Creatinine Before infusion	30.92 µmol/l Standard Deviation 15.32	31.08 µmol/l Standard Deviation 16.48
Serum Creatinine After infusion	30.23 µmol/l Standard Deviation 14.06	33.13 µmol/l Standard Deviation 17.80

SECONDARY outcome

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

Outcome measures

Measure	Gelofusine 4% n=121 Participants Children age ≤ 12 years Gelofusine 4%	Gelaspan 4% n=480 Participants Children age ≤ 12 years Gelaspan 4%
Number of Participants With (Serious) Adverse Events / Reactions	1 Participants	4 Participants

SECONDARY outcome

Timeframe: 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.

beats per minute

Outcome measures

Measure	Gelofusine 4% n=121 Participants Children age ≤ 12 years Gelofusine 4%	Gelaspan 4% n=480 Participants Children age ≤ 12 years Gelaspan 4%
Heart Rate Before infusion	116.74 beats per minute Standard Deviation 25.72	121.20 beats per minute Standard Deviation 22.54
Heart Rate After infusion	113.24 beats per minute Standard Deviation 22.54	118.72 beats per minute Standard Deviation 21.88

SECONDARY outcome

Timeframe: 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

mmHg

Outcome measures

Measure	Gelofusine 4% n=121 Participants Children age ≤ 12 years Gelofusine 4%	Gelaspan 4% n=480 Participants Children age ≤ 12 years Gelaspan 4%
Mean Arterial Pressure Before infusion	58.03 mmHg Standard Deviation 14.81	46.72 mmHg Standard Deviation 11.54
Mean Arterial Pressure After infusion	65.23 mmHg Standard Deviation 14.48	55.55 mmHg Standard Deviation 11.25

SECONDARY outcome

Timeframe: At discharge from the hospital or in-hospital 3 months after start of gelatine infusion, whatever occurs first.

Outcome measures

Measure	Gelofusine 4% n=121 Participants Children age ≤ 12 years Gelofusine 4%	Gelaspan 4% n=480 Participants Children age ≤ 12 years Gelaspan 4%
Follow-up Assessed by Number of Participants With Post-operative Complications	0 Participants	4 Participants

Adverse Events

Gelofusine 4%

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Gelaspan 4%

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Gelofusine 4% n=121 participants at risk Children age ≤ 12 years Gelofusine 4%	Gelaspan 4% n=480 participants at risk Children age ≤ 12 years Gelaspan 4%
Injury, poisoning and procedural complications Procedural hemorrhage	0.00% 0/121 • Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	0.21% 1/480 • Number of events 1 • Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

Other adverse events

Measure	Gelofusine 4% n=121 participants at risk Children age ≤ 12 years Gelofusine 4%	Gelaspan 4% n=480 participants at risk Children age ≤ 12 years Gelaspan 4%
Injury, poisoning and procedural complications Procedural nausea	0.83% 1/121 • Number of events 1 • Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	0.00% 0/480 • Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Vascular disorders Haemorrhage	0.83% 1/121 • Number of events 1 • Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	0.21% 1/480 • Number of events 1 • Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Metabolism and nutrition disorders Electrolyte imblance	0.00% 0/121 • Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	0.21% 1/480 • Number of events 1 • Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Injury, poisoning and procedural complications Hemodilution	0.00% 0/121 • Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions	0.21% 1/480 • Number of events 1 • Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions

Additional Information

Study Manager

B. Braun Melsungen

Phone: 05661/71

Email: studies@bbraun.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER