Study on the Efficacy and Safety of Gelaspan

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.

Study Overview

• Status: Completed
• Conditions: Hypovolemia
• Intervention / Treatment: Drug: Gelaspan 4%; Drug: Gelofusine 4%

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Saint-Petersburg, Russian Federation, 195271
    • Road Clinical Hospital of JSC "Russian Railways
  • Saint-Petersburg, Russian Federation, 197341
    • North-Western Federal Medical Research Center n.a. V.A. Almazov
  • Saint-Petersburg, Russian Federation, 198255
    • City Clinical Oncology Dispensary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: balanced gelatine solution; isotonic colloidal volume substitute	Drug: Gelaspan 4%; Gelaspan 4% combined with Sterofundin ISO
Active Comparator: non-balanced gelatine solution; colloidal volume substitute	Drug: Gelofusine 4%; Gelofusine 4% combined with Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Base Excess	Change in base excess from baseline to end of surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Base Excess	Change in base excess from baseline to 12 hours after end of surgery
Adverse events	until 12 hours after end of surgery
Hemodynamics	until 12 hours after end of surgery
Renal Function	until 12 hours after end of surgery
Arterial blood gas analysis	until 12 hours after end of surgery
Coagulation status	until 12 hours after end of surgery

Collaborators and Investigators

• Sponsor: B. Braun Medical LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: June 17, 2016
• First Submitted That Met QC Criteria: June 17, 2016
• First Posted (Estimate): June 21, 2016

Study Record Updates

• Last Update Posted (Actual): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia; Plasma Substitutes; Blood Substitutes; Polygeline
• Other Study ID Numbers: HC-G-H-1409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No