Clinical Trial: Regional Citrate Anticoagulation in Plasma Exchange Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Regional Citrate Anticoagulation in Plasma Exchange Treatment

Brief Summary:

The investigators want to compare the efficacy of plasma exchange treatment with using two different citrates ( 4% and 15% ) as anticoagulants in plasma exchange treatment.

The efficacy of plasma exchange treatment is better with using 15% trisodium citrate as anticoagulant during the plasma exchange procedure.


Detailed Summary: To compare the elimination rate of immunoglobulins in plasma exchange treatment by using two differently concentrated citrates for anticoagulation during plasma exchange procedure. At the same time we want to compare acid-base , electrolyte status and anticoagulation protocol in two citrate groups.
Sponsor: University Medical Centre Ljubljana

Current Primary Outcome: The efficacy of plasma exchange, measuring immunoglobulins type G before and after the procedure, using 4% and 15% citrate as anticoagulants [ Time Frame: the whole trial, approximately 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The percentage of patients in whom there is a 50% reduction of immunoglobulins after plasma exchange using 4% and 15% citrate as anticoagulants [ Time Frame: the whole trial, approximately 3 years ]
  • Using 15% citrate as an anticoagulant during plasma exchange treatment is as safe as using 4% citrate as anticoagulant during plasma exchange treatment. [ Time Frame: the whole trial, approximately 3 years ]


Original Secondary Outcome: Same as current

Information By: University Medical Centre Ljubljana

Dates:
Date Received: June 2, 2011
Date Started: April 2011
Date Completion:
Last Updated: May 26, 2015
Last Verified: May 2015