Back to resultsComparison of Citrate and Heparin Anticoagulation During Hemodialysis With MCO PES-PVP (Theranova) Membrane
Primary Purpose
End Stage Renal Disease, Haemodialysis, Anticoagulation
Status
Active
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
unfractionated heparin
8% trisodium citrate
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease
Eligibility Criteria
Inclusion Criteria:
- patient on chronic hemodialysis
- age 18 years old or more
- being able to give an informed consent to participate in the survey
Exclusion Criteria:
- on therapeutic anticoagulation
- citrate or heparin contraindicated
- citrate or heparin intolerance
- acute renal failure
Sites / Locations
- University Medical Centre Ljubljana
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
unfractionated heparin and 8% trisodium citrate
Arm Description
Unfractionated heparin and 8% trisodium citrate.
Outcomes
Primary Outcome Measures
Clearance of beta-2 microglobulin
Overall and instantaneous clearance of beta-2 microglobulin.
Clearance of phosphate
Overall and instantaneous clearance of phosphate.
Serum concentration of C3a, C5a, myeloperoxidase and PF-4
Blood for the laboratory measurements will be taken from the arterial line.
Secondary Outcome Measures
Clearance of urea
Overall and instantaneous clearance of urea.
Clearance of creatinine
Overall and instantaneous clearance of creatinine.
Clearance of p-cresol
Overall and instantaneous clearance of p-cresol.
White blood cell count
Blood for the laboratory measurements will be taken from the arterial line.
Blood platelet count
Blood for the laboratory measurements will be taken from the arterial line.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04139525
Brief Title
Comparison of Citrate and Heparin Anticoagulation During Hemodialysis With MCO PES-PVP (Theranova) Membrane
Official Title
Comparison of Citrate and Heparin Anticoagulation During Hemodialysis With Medium Cut-off Polyarylethersulphone- Polyvinylpirrolidone (Theranova) Membrane
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marija Malgaj Vrečko
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis with medium cut-off polyarylethersulphone-polyvinylpirrolidone membrane (Theranova®).
Detailed Description
The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis (HD) with PES-PVP membrane. The research will be performed as a prospective clinical trial and will include 35 patients. Every patient will have 2 HD procedures with PES-PVP membrane in a randomized order: 1 with unfractionated heparin (UFH) and 1 with 8% trisodium citrate. We will compare the efficiency of both types of anticoagulation by measuring overall and instantaneous clearances of small, middle and protein-bound molecules (urea, creatinine, phosphate, β2-microglobulin, p-cresol). Biocompatibility will be evaluated by measuring activation of: complement (serum concentration of C3a and C5a), leukocytes (serum concentration of myeloperoxidase) and thrombocytes (serum concentration of PF4). We will also monitor complete blood count for occurrence of leukopenia and thrombocytopenia. After the HD electron microscopy of the membrane will be done in the proportion of included patients to evaluate adsorption of cells and formation of blood clots on the membrane.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Haemodialysis, Anticoagulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The research will be performed as a prospective clinical trial. Every patient will have 2 HD procedures with PES-PVP membrane in a randomized order: 1 with unfractionated heparin (UFH) and 1 with 8% trisodium citrate.
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
unfractionated heparin and 8% trisodium citrate
Arm Type
Experimental
Arm Description
Unfractionated heparin and 8% trisodium citrate.
Intervention Type
Biological
Intervention Name(s)
unfractionated heparin
Intervention Description
A bolus of 30 I.U./kg at the start of hemodialysis, followed by 18 I.U./kg per every hour of hemodialysis.
Intervention Type
Biological
Intervention Name(s)
8% trisodium citrate
Intervention Description
8% trisodium citrate in the dose of 150 ml/h.
Primary Outcome Measure Information:
Title
Clearance of beta-2 microglobulin
Description
Overall and instantaneous clearance of beta-2 microglobulin.
Time Frame
At the end of each hemodialysis procedure.
Title
Clearance of phosphate
Description
Overall and instantaneous clearance of phosphate.
Time Frame
At the end of each hemodialysis procedure.
Title
Serum concentration of C3a, C5a, myeloperoxidase and PF-4
Description
Blood for the laboratory measurements will be taken from the arterial line.
Time Frame
At the start, after 15 minutes and at the end of each hemodialysis procedure.
Secondary Outcome Measure Information:
Title
Clearance of urea
Description
Overall and instantaneous clearance of urea.
Time Frame
At the end of each hemodialysis procedure.
Title
Clearance of creatinine
Description
Overall and instantaneous clearance of creatinine.
Time Frame
At the end of each hemodialysis procedure.
Title
Clearance of p-cresol
Description
Overall and instantaneous clearance of p-cresol.
Time Frame
At the end of each hemodialysis procedure.
Title
White blood cell count
Description
Blood for the laboratory measurements will be taken from the arterial line.
Time Frame
At the start, after 15 minutes and at the end of each hemodialysis procedure.
Title
Blood platelet count
Description
Blood for the laboratory measurements will be taken from the arterial line.
Time Frame
At the start, after 15 minutes and at the end of each hemodialysis procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient on chronic hemodialysis
age 18 years old or more
being able to give an informed consent to participate in the survey
Exclusion Criteria:
on therapeutic anticoagulation
citrate or heparin contraindicated
citrate or heparin intolerance
acute renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marija Malgaj Vrečko, MD
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36303108
Citation
Vrecko MM, Pajek J, Buturovic-Ponikvar J. Use of regional citrate anticoagulation with medium cut-off membrane: pilot report. BMC Nephrol. 2022 Oct 27;23(1):346. doi: 10.1186/s12882-022-02960-y.
Results Reference
derived
Learn more about this trial
Comparison of Citrate and Heparin Anticoagulation During Hemodialysis With MCO PES-PVP (Theranova) Membrane
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