HypovolemiaPhase 3NCT02808325
Study on the Efficacy and Safety of Gelaspan
A Phase 3 study testing Gelaspan 4% and Gelofusine 4% in people with Hypovolemia, run by B. Braun Medical LLC at 3 sites in Russia.
Trial summary
It is the objective of the study to investigate the efficacy and safety of two different volume replacement regimens with gelatine solutions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypovolemia
- What is being tested?
- Gelaspan 4% and Gelofusine 4%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesRussia
- Study dates
- Jun 2016to Jun 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
Road Clinical Hospital of JSC "Russian Railways
Saint Petersburg, 195271
North-Western Federal Medical Research Center n.a. V.A. Almazov
Saint Petersburg, 197341
City Clinical Oncology Dispensary
Saint Petersburg, 198255
About this study
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
It is the objective of the study to investigate the efficacy and safety of two different volume replacement regimens with gelatine solutions.
- Conditions
- Hypovolemia
- Being tested
- Gelaspan 4%, Gelofusine 4%
- Medical subject headings
- Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelaspan 4%Drug
Gelaspan 4% combined with Sterofundin ISO
Gelofusine 4%Drug
Gelofusine 4% combined with Sodium Chloride
| Study group | Role | What they receive |
|---|---|---|
| balanced gelatine solution | Experimental | isotonic colloidal volume substitute Receives: Drug: Gelaspan 4% |
| non-balanced gelatine solution | Active comparator | colloidal volume substitute Receives: Drug: Gelofusine 4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Base Excess
Measured: Change in base excess from baseline to end of surgery
Secondary outcomes (6)
Base Excess
Measured: Change in base excess from baseline to 12 hours after end of surgery
Adverse events
Measured: until 12 hours after end of surgery
Hemodynamics
Measured: until 12 hours after end of surgery
Renal Function
Measured: until 12 hours after end of surgery
Arterial blood gas analysis
Measured: until 12 hours after end of surgery
Coagulation status
Measured: until 12 hours after end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Medical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808325
- Sponsor's protocol ID
- HC-G-H-1409
- Status last verified
- Apr 2017
- First submitted
- 17 Jun 2016
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02808325
- Acronym / sponsor ID
- HC-G-H-1409
- Conditions
- Hypovolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- B. Braun Medical LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is the objective of the study to investigate the efficacy and safety of two different volume replacement regimens with gelatine solutions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| balanced gelatine solution | Experimental | Drug: Gelaspan 4%isotonic colloidal volume substitute |
| non-balanced gelatine solution | Active comparator | Drug: Gelofusine 4%colloidal volume substitute |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (23 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gelaspan 4%Gelaspan 4% combined with Sterofundin ISO | Drug | balanced gelatine solution |
| Gelofusine 4%Gelofusine 4% combined with Sodium Chloride | Drug | non-balanced gelatine solution |
Primary outcome
Base Excess
Time frame: Change in base excess from baseline to end of surgery
6 secondary outcomes
Base Excess
Time frame: Change in base excess from baseline to 12 hours after end of surgery
Adverse events
Time frame: until 12 hours after end of surgery
Hemodynamics
Time frame: until 12 hours after end of surgery
Renal Function
Time frame: until 12 hours after end of surgery
Arterial blood gas analysis
Time frame: until 12 hours after end of surgery
Coagulation status
Time frame: until 12 hours after end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gelaspan 4% and Gelofusine 4% in people with Hypovolemia, run by B. Braun Medical LLC at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Base Excess (time frame: Change in base excess from baseline to end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.