Study on the Efficacy and Safety of Gelaspan

Study Overview
=================
Brief Summary
-----------------
It is the objective of the study to investigate the efficacy and safety of two different volume replacement regimens with gelatine solutions.

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

Conditions
-----------------
Hypovolemia

Intervention / Treatment
-----------------
* Drug: Gelaspan 4%
* Drug: Gelofusine 4%


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |