Regional Citrate Anticoagulation in Plasma Exchange Treatment

Focal Segmental Glomerulosclerosis Clinical Trial

Official title:

Regional Citrate Anticoagulation in Plasma Exchange Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370200
• Other study ID #: 111/09/09
• Status: Completed
• Phase: N/A
• First received: June 2, 2011
• Last updated: May 26, 2015
• Start date: April 2011
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients who need plasma exchange treatment

• human albumins as a replacement fluid

Exclusion Criteria:

• anemia Hb less than 90

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Focal Segmental Glomerulosclerosis
• Glomerulosclerosis, Focal Segmental
• Guillain-Barre Syndrome

Intervention

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

Locations

Country	Name	City	State
Slovenia	Center for acute and complicated dialysis, Clinical department of nephrology, UMC Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (1)

Antonic M, Gubensek J, Buturovic-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of plasma exchange, measuring immunoglobulins type G before and after the procedure, using 4% and 15% citrate as anticoagulants		the whole trial, approximately 3 years	No
Secondary	The percentage of patients in whom there is a 50% reduction of immunoglobulins after plasma exchange using 4% and 15% citrate as anticoagulants		the whole trial, approximately 3 years	No
Secondary	Using 15% citrate as an anticoagulant during plasma exchange treatment is as safe as using 4% citrate as anticoagulant during plasma exchange treatment.		the whole trial, approximately 3 years	No