Study on the Efficacy and Safety of Gelaspan

Hypovolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808325
• Other study ID #: HC-G-H-1409
• Status: Completed
• Phase: Phase 3
• First received: June 17, 2016
• Last updated: August 10, 2017
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: April 2017
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypovolemia

Intervention

Drug:
• Gelaspan 4%
Gelaspan 4% combined with Sterofundin ISO
• Gelofusine 4%
Gelofusine 4% combined with Sodium Chloride

Locations

Country	Name	City	State
Russian Federation	City Clinical Oncology Dispensary	Saint-Petersburg
Russian Federation	North-Western Federal Medical Research Center n.a. V.A. Almazov	Saint-Petersburg
Russian Federation	Road Clinical Hospital of JSC "Russian Railways	Saint-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Medical LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Base Excess		Change in base excess from baseline to end of surgery
Secondary	Base Excess		Change in base excess from baseline to 12 hours after end of surgery
Secondary	Adverse events		until 12 hours after end of surgery
Secondary	Hemodynamics		until 12 hours after end of surgery
Secondary	Renal Function		until 12 hours after end of surgery
Secondary	Arterial blood gas analysis		until 12 hours after end of surgery
Secondary	Coagulation status		until 12 hours after end of surgery