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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gelofusine 4% | Children age ≤ 12 years |
| |
| Gelaspan 4% | Children age ≤ 12 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gelofusine 4% | Drug |
| ||
| Gelaspan 4% |
| Measure | Description | Time Frame |
|---|---|---|
| Dosing of the Products During Surgery | Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions |
| Measure | Description | Time Frame |
|---|---|---|
| Potentia Hydrogenii | 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 |
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Inclusion:
Exclusion:
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children
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| Name | Affiliation | Role |
|---|---|---|
| Robert Sümpelmann, Prof. | Medizinische Hochschule Hannover (MHH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cardiology Hospital | Sofia | 1606 | Bulgaria | |||
| Auf der Bult |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35588274 | Derived | Rudolf D, Witt L, Boethig D, Rigterink V, Zander R, Sumpelmann R, Dennhardt N. The impact of modified fluid gelatin 4% in a balanced electrolyte solution on plasma osmolality in children-A noninterventional observational study. Paediatr Anaesth. 2022 Aug;32(8):961-966. doi: 10.1111/pan.14494. Epub 2022 May 31. |
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Enrolment target of 1500 patients was not met due to slow recruitment although duration of study had been extended to 60 months
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| ID | Title | Description |
|---|---|---|
| FG000 | Gelofusine 4% | Children age ≤ 12 years Gelofusine 4% |
| FG001 | Gelaspan 4% | Children age ≤ 12 years Gelaspan 4% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gelofusine 4% | Children age ≤ 12 years Gelofusine 4% |
| BG001 | Gelaspan 4% | Children age ≤ 12 years Gelaspan 4% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dosing of the Products During Surgery | Posted | Mean | Standard Deviation | ml/kg | 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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gelofusine 4% | Children age ≤ 12 years Gelofusine 4% | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural hemorrhage | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Manager | B. Braun Melsungen | 05661/71 | 0 | studies@bbraun.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2019 | Feb 9, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012769 | Shock |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
mmol/L
| Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions |
| Lactate | mmol/l | 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 | mmol/l | Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions |
| Serum Prolin | µmol/l | Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions |
| Serum Creatinine | µmol/l | 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 | beats per minute | Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions |
| Mean Arterial Pressure | 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 | At discharge from the hospital or in-hospital 3 months after start of gelatine infusion, whatever occurs first. |
| Hanover |
| 30173 |
| Germany |
| Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin | Hanover | 30625 | Germany |
| Klinik Hallerwiese/Cnopf´sche Kinderklinik | Nuremberg | 90419 | Germany |
| Klinikum Stuttgart, Olgahospital und Frauenklinik | Stuttgart | 70174 | Germany |
| Azienda Policlinico Universitaria G. Rodolico -Vittorio Emanuele | Catania | I-95100 | Italy |
| Ospedale dei Bambini Vittore Buzzi | Milan | I-20154 | Italy |
| Hospital de Sant Joan de Déu | Barcelona | Spain |
| Vall d'Hebron University Hospital | Barcelona | Spain |
| Hospital Son Espases | Palma de Mallorca | Spain |
| Alder Hey Children's NHS FT | Liverpool | L12 2AP | United Kingdom |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Potentia Hydrogenii | Potentia hydrogenii (ph) was part of blood sampling/laboratory to measure the levels of oxygen and carbon dioxide. | The data for potentia hydrogenii were not entered for all partipants by the sites in the data collection form. | Posted | Mean | Standard Deviation | unitless | Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions |
|
|
|
| Secondary | Hemoglobin | mmol/L | The data for Hemoglobin were not entered for all participants by the sites in the data collection form. | Posted | Mean | Standard Deviation | mmol/L | Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions |
|
|
|
| Secondary | Lactate | mmol/l | The data for lactates were not entered for all participants by the sites in the data collection form. | Posted | Mean | Standard Deviation | mmol/l | Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions |
|
|
|
| Secondary | Hematocrit | % | The data for Hematocrit were not entered for all subjects by the sites in the data collection form. | Posted | Mean | Standard Error | "%" | Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions |
|
|
|
| Secondary | Glucose | mmol/l | The data for glucose were not entered for all participants by the sites in the data collection form | Posted | Mean | Standard Deviation | mmol/l | Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions |
|
|
|
| Secondary | Serum Prolin | µmol/l | Serum proline was only documented in four study participants in total. Not part of clinical routine. | Posted | Mean | Standard Deviation | µmol/l | Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions |
|
|
|
| Secondary | Serum Creatinine | µmol/l | The data for Serum Creatinine were not entered for all participants by the sites in the data collection form. | Posted | Mean | Standard Deviation | µmol/l | Before (0 - 2 days) and up to 2 days after infusion of gelatin solutions |
|
|
|
| Secondary | Number of Participants With (Serious) Adverse Events / Reactions | Posted | Count of Participants | Participants | Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions |
|
|
|
| Secondary | Heart Rate | beats per minute | The data for heart rate were not entered for all participants by the sites in the data collection form. | Posted | Mean | Standard Deviation | beats per minute | Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions |
|
|
|
| Secondary | Mean Arterial Pressure | mmHg | The data for mean arterial pressure were not entered for all participants by the sites in the data collection form | Posted | Mean | Standard Deviation | mmHg | Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions |
|
|
|
| Secondary | Follow-up Assessed by Number of Participants With Post-operative Complications | Posted | Count of Participants | Participants | At discharge from the hospital or in-hospital 3 months after start of gelatine infusion, whatever occurs first. |
|
|
|
| 121 |
| 0 |
| 121 |
| 1 |
| 121 |
| EG001 | Gelaspan 4% | Children age ≤ 12 years Gelaspan 4% | 0 | 480 | 1 | 480 | 3 | 480 |
| Haemorrhage | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Electrolyte imblance | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hemodilution | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
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| After infusion |
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| After infusion |
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| After infusion |
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| After infusion |
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