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Trial record 12 of 20 for:    Guillain-Barré Syndrome
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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
  Purpose

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.


Condition Intervention
Focal Segmental Glomerulosclerosis
Guillain-Barre Syndrome
 Procedure: plasma exchange treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Regional Citrate Anticoagulation in Plasma Exchange Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 140
Study Start Date: April 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 4% citrate 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: 15% citrate 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • anemia Hb less than 90
  • hepatitis infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370200

Contacts
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

Locations
Slovenia
Center for acute and complicated dialysis, Clinical department of nephrology, UMC Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Manja Antonič, MD     +386 1 522 3328     manja.antonic1@gmail.com    
Contact: Rafael Ponikvar, MD,PhD,Prof     +386 1 522 3328     rafael.ponikvar@kclj.si    
Principal Investigator: Manja Antonič, MD            
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Principal Investigator: Manja Antonič, MD Center for acute and complicated dialysis, UMCLjubljana
  More Information

Publications:

Responsible Party: Manja Antonič, MD , Professor Rafael Ponikvar, MD, PhD, UMC Ljubljana, Center for acute and complicated dialisys
ClinicalTrials.gov Identifier: NCT01370200     History of Changes
Other Study ID Numbers: 111/09/09
Study First Received: June 2, 2011
Last Updated: June 8, 2011
Health Authority: Slovenia: Ethics Committee

Keywords provided by University Medical Centre Ljubljana:
citrate
anticoagulation
plasma exchange
efficacy

Additional relevant MeSH terms:
Guillain-Barre Syndrome
Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
Immune System Diseases
Citric Acid
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013