Study on the Efficacy and Safety of Gelaspan
Primary Purpose
Hypovolemia
Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Gelaspan 4%
Gelofusine 4%
Sponsored by
About this trial
This is an interventional treatment trial for Hypovolemia
Eligibility Criteria
Inclusion:
- Male or female patients ≥ 18 years of age and ≤ 80 years of age.
- Patients scheduled to undergo open elective abdominal or pelvic surgery.
- Anticipated intraoperative volume requirement for gelatine solution is at least 15 mL/kg body weight
- Negative pregnancy test (urine dipsticks) in women of child bearing potential.
- Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the regulatory authorities of the Russian Federation and Local Ethics Committee (LEC) prior to all evaluations.
Exclusion:
- Patients of ASA-class > III.
- Known hypersensitivity to gelatine or to any of the constituents of the solution.
- Patients treated with other colloid solutions and / or blood products 24 hours prior to surgery.
- Patients on hemodialysis.
Patients suffering from:
- Decompensated renal function (i.e. serum creatinine > 3.0 mg/dL)
- Hypervolemia;
- Severe heart failure;
- Moderate lung edema;
- Hyperhydration;
- Severe blood coagulation disorders (aPTT >2.5 x ULN or fibrinogen < 0.5 x LLN or INR >2.5 x ULN);
- Hypernatremia (serum Na+ > 150 mmol/L);
- Hyperchloremia (serum Cl- > 110 mmol/L);
- Hypercalcemia (serum ionized Ca++ > 1.5 mmol/L);
- Metabolic alkalosis;
- Severe generalized edema;
- Intracranial haemorrhage;
- Hyperkalemia (serum K+ > 5.5 mmol/L).
- Pregnancy and/or nursing.
- Hypertension with the Systolic Blood Pressure > 180 mm Hg and Diastolic Blood Pressure > 110 mm Hg identified at screening.
- Patients who in the investigator's opinion couldn't take part in the study.
- Simultaneous participation in another clinical trial.
- Emergencies.
Sites / Locations
- Road Clinical Hospital of JSC "Russian Railways
- North-Western Federal Medical Research Center n.a. V.A. Almazov
- City Clinical Oncology Dispensary
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
balanced gelatine solution
non-balanced gelatine solution
Arm Description
isotonic colloidal volume substitute
colloidal volume substitute
Outcomes
Primary Outcome Measures
Base Excess
Secondary Outcome Measures
Base Excess
Adverse events
Hemodynamics
Renal Function
Arterial blood gas analysis
Coagulation status
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02808325
Brief Title
Study on the Efficacy and Safety of Gelaspan
Official Title
Prospective Controlled Randomized Double-blind Multicentre Study in Parallel Groups on the Efficacy and Safety of Gelaspan in Combination With Sterofundin ISO in Comparison With Gelofusine in Combination With Sodium Chloride Braun in Patients Scheduled for Abdominal or Pelvic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
B. Braun Medical LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is the objective of the study to investigate the efficacy and safety of two different volume replacement regimens with gelatine solutions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
balanced gelatine solution
Arm Type
Experimental
Arm Description
isotonic colloidal volume substitute
Arm Title
non-balanced gelatine solution
Arm Type
Active Comparator
Arm Description
colloidal volume substitute
Intervention Type
Drug
Intervention Name(s)
Gelaspan 4%
Intervention Description
Gelaspan 4% combined with Sterofundin ISO
Intervention Type
Drug
Intervention Name(s)
Gelofusine 4%
Intervention Description
Gelofusine 4% combined with Sodium Chloride
Primary Outcome Measure Information:
Title
Base Excess
Time Frame
Change in base excess from baseline to end of surgery
Secondary Outcome Measure Information:
Title
Base Excess
Time Frame
Change in base excess from baseline to 12 hours after end of surgery
Title
Adverse events
Time Frame
until 12 hours after end of surgery
Title
Hemodynamics
Time Frame
until 12 hours after end of surgery
Title
Renal Function
Time Frame
until 12 hours after end of surgery
Title
Arterial blood gas analysis
Time Frame
until 12 hours after end of surgery
Title
Coagulation status
Time Frame
until 12 hours after end of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion:
Male or female patients ≥ 18 years of age and ≤ 80 years of age.
Patients scheduled to undergo open elective abdominal or pelvic surgery.
Anticipated intraoperative volume requirement for gelatine solution is at least 15 mL/kg body weight
Negative pregnancy test (urine dipsticks) in women of child bearing potential.
Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the regulatory authorities of the Russian Federation and Local Ethics Committee (LEC) prior to all evaluations.
Exclusion:
Patients of ASA-class > III.
Known hypersensitivity to gelatine or to any of the constituents of the solution.
Patients treated with other colloid solutions and / or blood products 24 hours prior to surgery.
Patients on hemodialysis.
Patients suffering from:
Decompensated renal function (i.e. serum creatinine > 3.0 mg/dL)
Hypervolemia;
Severe heart failure;
Moderate lung edema;
Hyperhydration;
Severe blood coagulation disorders (aPTT >2.5 x ULN or fibrinogen < 0.5 x LLN or INR >2.5 x ULN);
Hypernatremia (serum Na+ > 150 mmol/L);
Hyperchloremia (serum Cl- > 110 mmol/L);
Hypercalcemia (serum ionized Ca++ > 1.5 mmol/L);
Metabolic alkalosis;
Severe generalized edema;
Intracranial haemorrhage;
Hyperkalemia (serum K+ > 5.5 mmol/L).
Pregnancy and/or nursing.
Hypertension with the Systolic Blood Pressure > 180 mm Hg and Diastolic Blood Pressure > 110 mm Hg identified at screening.
Patients who in the investigator's opinion couldn't take part in the study.
Simultaneous participation in another clinical trial.
Emergencies.
Facility Information:
Facility Name
Road Clinical Hospital of JSC "Russian Railways
City
Saint-Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
North-Western Federal Medical Research Center n.a. V.A. Almazov
City
Saint-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
City Clinical Oncology Dispensary
City
Saint-Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
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Study on the Efficacy and Safety of Gelaspan
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