Regional Citrate Anticoagulation in Plasma Exchange Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University Medical Centre Ljubljana
Sponsor:
Information provided by (Responsible Party):
Manja Antonic, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT01370200
First received: June 2, 2011
Last updated: February 3, 2014
Last verified: February 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370200

Contacts
Contact: Manja Antonič, MD 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 Antonic, MD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT01370200     History of Changes
Other Study ID Numbers: 111/09/09
Study First Received: June 2, 2011
Last Updated: February 3, 2014
Health Authority: Slovenia: Ethics Committee

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

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Guillain-Barre Syndrome
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
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014