Regional Citrate Anticoagulation in Plasma Exchange Treatment

NCT01370200 | Completed

• 1 other identifier: 111/09/09
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Focal Segmental Glomerulosclerosis; Guillain-Barre Syndrome

Keywords

citrate; anticoagulation; plasma exchange; efficacy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

4% citrate

ACTIVE COMPARATOR

4% trisodium citrate, starting infusion rate 180 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step

Procedure: plasma exchange treatment

15% citrate

ACTIVE COMPARATOR

15% trisodium citrate, starting infusion rate 50 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step

Procedure: plasma exchange treatment

Interventions

plasma exchange treatment PROCEDURE

the therapeutic plasma exchange is the procedure of removing the plasma of the patient including pathological macromolecules and replacing it with the replacement fluid

15% citrate; 4% citrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• anemia Hb less than 90

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

Center for acute and complicated dialysis, Clinical department of nephrology, UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

Related 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.

  PMID: 19695068 BACKGROUND

MeSH Terms

Conditions

Glomerulosclerosis, Focal Segmental; Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manja Antonič, MD

  Center for acute and complicated dialysis, UMCLjubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 9, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

SL (1)