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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04139525
Other study ID # 0120-11/2019/3
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date December 2022

Study information

Verified date June 2022
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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®).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 32
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Biological:
unfractionated heparin
A bolus of 30 I.U./kg at the start of hemodialysis, followed by 18 I.U./kg per every hour of hemodialysis.
8% trisodium citrate
8% trisodium citrate in the dose of 150 ml/h.

Locations

Country Name City State
Slovenia University Medical Centre Ljubljana Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
Marija Malgaj Vrecko

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clearance of beta-2 microglobulin Overall and instantaneous clearance of beta-2 microglobulin. At the end of each hemodialysis procedure.
Primary Clearance of phosphate Overall and instantaneous clearance of phosphate. At the end of each hemodialysis procedure.
Primary Serum concentration of C3a, C5a, myeloperoxidase and PF-4 Blood for the laboratory measurements will be taken from the arterial line. At the start, after 15 minutes and at the end of each hemodialysis procedure.
Secondary Clearance of urea Overall and instantaneous clearance of urea. At the end of each hemodialysis procedure.
Secondary Clearance of creatinine Overall and instantaneous clearance of creatinine. At the end of each hemodialysis procedure.
Secondary Clearance of p-cresol Overall and instantaneous clearance of p-cresol. At the end of each hemodialysis procedure.
Secondary White blood cell count Blood for the laboratory measurements will be taken from the arterial line. At the start, after 15 minutes and at the end of each hemodialysis procedure.
Secondary Blood platelet count Blood for the laboratory measurements will be taken from the arterial line. At the start, after 15 minutes and at the end of each hemodialysis procedure.
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