Study on the Efficacy and Safety of Gelaspan

NCT02808325 | Completed Phase 3

• 1 other identifier: HC-G-H-1409
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

Brief Summary

It is the objective of the study to investigate the efficacy and safety of two different volume replacement regimens with gelatine solutions.

Conditions

Hypovolemia

Outcome Measures

Primary Outcomes (1)

• Base Excess

  Change in base excess from baseline to end of surgery

Secondary Outcomes (6)

• 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

Study Arms (2)

balanced gelatine solution

EXPERIMENTAL

isotonic colloidal volume substitute

Drug: Gelaspan 4%

non-balanced gelatine solution

ACTIVE COMPARATOR

colloidal volume substitute

Drug: Gelofusine 4%

Interventions

Gelaspan 4% DRUG

Gelaspan 4% combined with Sterofundin ISO

balanced gelatine solution

Gelofusine 4% DRUG

Gelofusine 4% combined with Sodium Chloride

non-balanced gelatine solution

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• B. Braun Medical LLC: lead

Study Sites (3)

Road Clinical Hospital of JSC "Russian Railways

Saint Petersburg, 195271, Russia

Location

North-Western Federal Medical Research Center n.a. V.A. Almazov

Saint Petersburg, 197341, Russia

Location

City Clinical Oncology Dispensary

Saint Petersburg, 198255, Russia

Location

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: June 21, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 11, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)