Clinical Trial: Study on the Efficacy and Safety of Gelaspan

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Combinat

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

Detailed Summary:
Sponsor: B. Braun Medical LLC

Current Primary Outcome: Base Excess [ Time Frame: Change in base excess from baseline to end of surgery ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: B. Braun Melsungen AG

Dates:
Date Received: June 17, 2016
Date Started: June 2016
Date Completion: May 2017
Last Updated: April 19, 2017
Last Verified: April 2017