Study on the Efficacy and Safety of Gelaspan

B. Braun

Status and phase: Completed; Phase 3

Conditions: Hypovolemia

Treatments: Drug: Gelaspan 4%; Drug: Gelofusine 4%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02808325

HC-G-H-1409

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups

balanced gelatine solution

Experimental group

Description:

isotonic colloidal volume substitute

Treatment:

Drug: Gelaspan 4%

non-balanced gelatine solution

Active Comparator group

Description:

colloidal volume substitute

Treatment:

Drug: Gelofusine 4%