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Regional Citrate Anticoagulation in Plasma Exchange Treatment

This study is currently recruiting participants.
Verified December 2009 by University Medical Centre Ljubljana
Sponsor:
Information provided by:
University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT01370200
First received: June 2, 2011
Last updated: June 8, 2011
Last verified: December 2009
History of Changes

June 2, 2011
June 8, 2011
April 2011
December 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01370200 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Regional Citrate Anticoagulation in Plasma Exchange Treatment
Regional Citrate Anticoagulation in Plasma Exchange Treatment

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Focal Segmental Glomerulosclerosis
  • Guillain-Barre Syndrome
Procedure: plasma exchange treatment
the therapeutic plasma exchange is the procedure of removing the plasma of the patient including pathological macromolecules and replacing it with the replacement fluid
  • Active Comparator: 4% citrate
    Intervention: Procedure: plasma exchange treatment
  • Active Comparator: 15% citrate
    Intervention: Procedure: plasma exchange treatment
Antonic M, Gubensek J, Buturovi?-Ponikvar J, Ponikvar R. Comparison of citrate anticoagulation during plasma exchange with different replacement solutions. Ther Apher Dial. 2009 Aug;13(4):322-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients who need plasma exchange treatment
  • human albumins as a replacement fluid

Exclusion Criteria:

  • anemia Hb less than 90
  • hepatitis infection
Both
18 Years and older
No
Contact: Manja Antonič, MD +386 41 731 753 manja.antonic1@gmail.com
Contact: Rafael Ponikvar, MD,PhD,Prof +386 1 522 3328 rafael.ponikvar@kclj.si
Slovenia
 
NCT01370200
111/09/09
No
Manja Antonič, MD , Professor Rafael Ponikvar, MD, PhD, UMC Ljubljana, Center for acute and complicated dialisys
University Medical Centre Ljubljana
Not Provided
Principal Investigator: Manja Antonič, MD Center for acute and complicated dialysis, UMCLjubljana
University Medical Centre Ljubljana
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP