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Regional Citrate Anticoagulation in Plasma Exchange Treatment

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ClinicalTrials.gov Identifier: NCT01370200
Recruitment Status : Completed
First Posted : June 9, 2011
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Manja Antonic, University Medical Centre Ljubljana

Tracking Information
First Submitted Date  ICMJE June 2, 2011
First Posted Date  ICMJE June 9, 2011
Last Update Posted Date May 27, 2015
Study Start Date  ICMJE April 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2011)
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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01370200 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2011)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Regional Citrate Anticoagulation in Plasma Exchange Treatment
Official Title  ICMJE 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 Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Focal Segmental Glomerulosclerosis
  • Guillain-Barre Syndrome
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: 4% citrate
    4% trisodium citrate, starting infusion rate 180 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step
    Intervention: Procedure: plasma exchange treatment
  • Active Comparator: 15% citrate
    15% trisodium citrate, starting infusion rate 50 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step
    Intervention: Procedure: plasma exchange treatment
Publications * Antonic M, Gubensek J, Buturović-Ponikvar J, Ponikvar R. Comparison of citrate anticoagulation during plasma exchange with different replacement solutions. Ther Apher Dial. 2009 Aug;13(4):322-6. doi: 10.1111/j.1744-9987.2009.00733.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2011)
140
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • anemia Hb less than 90
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01370200
Other Study ID Numbers  ICMJE 111/09/09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Manja Antonic, University Medical Centre Ljubljana
Study Sponsor  ICMJE University Medical Centre Ljubljana
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manja Antonič, MD Center for acute and complicated dialysis, UMCLjubljana
PRS Account University Medical Centre Ljubljana
Verification Date May 2015

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