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Completed

NCT Number: NCT01370200

Regional Citrate Anticoagulation in Plasma Exchange Treatment

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • anemia Hb less than 90

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 9, 2011
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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