- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01370200
Regional Citrate Anticoagulation in Plasma Exchange Treatment
May 26, 2015 updated by: Manja Antonic, University Medical Centre Ljubljana
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ljubljana, Slovenia, 1000
- Center for acute and complicated dialysis, Clinical department of nephrology, UMC Ljubljana
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients who need plasma exchange treatment
- human albumins as a replacement fluid
Exclusion Criteria:
- anemia Hb less than 90
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 4% citrate
4% trisodium citrate, starting infusion rate 180 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step
|
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
15% trisodium citrate, starting infusion rate 50 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step
|
the therapeutic plasma exchange is the procedure of removing the plasma of the patient including pathological macromolecules and replacing it with the replacement fluid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
the whole trial, approximately 3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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.
Time Frame: the whole trial, approximately 3 years
|
the whole trial, approximately 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Manja Antonič, MD, Center for acute and complicated dialysis, UMCLjubljana
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
June 2, 2011
First Submitted That Met QC Criteria
June 8, 2011
First Posted (Estimate)
June 9, 2011
Study Record Updates
Last Update Posted (Estimate)
May 27, 2015
Last Update Submitted That Met QC Criteria
May 26, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Kidney Diseases
- Urologic Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Nephritis
- Glomerulonephritis
- Polyradiculoneuropathy
- Polyneuropathies
- Glomerulosclerosis, Focal Segmental
- Guillain-Barre Syndrome
Other Study ID Numbers
- 111/09/09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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