Anticoagulation in Chronic Hemodialysis Patients Versus Hemodialyzer Fiber Patency, Bleedings and Quality of Life (ClotSigns)

Mapping of Anticoagulation in Chronic Hemodialysis Patients Versus Hemodialyzer Fiber Patency, Bleedings and Quality of Life

Stable chronic hemodialysis patients are included in this observational study. After a midweek dialysis (test moment 1), the hemodialyzer is dried and scanned in a micro Computed Tomography scanner to quantify the number of patent fibers. All dialysis parameters are collected as well as the anticoagulation dose. During the same session, patients are asked about their bleeding and quality of life status. Four (test moment 2) respectively eight weeks later (test moment 3), patients are asked again for their bleeding and quality of life status using validated questionnaires.

Study Overview

• Status: Completed
• Conditions: Blood Coagulation
• Intervention / Treatment: Other: Hemodialyzer scanning; Other: Bleeding Questionnaires; Other: Quality of life questionnaire; Other: Visual inspection of the limbs

Detailed Description

All stable chronic hemodialysis (HD) patients having daytime dialysis in the Ghent University Hospital, are included.

From the patient's record, data are collected: demographic data (i.e. age, weight, dialysis vintage), blood data related to clotting (i.e. number of platelets, hemoglobin, International Normalized Ratio (INR), C-reactive protein (CRP)). All data is pseudomized.

The study has three test moments. During the entire study, patients are dialyzed with their usual dialyzer on their usual dialysis machine and with their usual dialysis settings and anticoagulation dosis. After the first midweek test session (test moment 1), the used hemodialyzer is rinsed with the standard rinsing procedure, dried in blood and dialysate compartment with positive pressure ventilation during 12-24h, eventually stored at 5°C, and finally scanned in a micro-CT scan in order to quantify the number of patent fibers. The dialyzer is vertically mounted on a rotating disc in front of the X-ray bundle. Scans are made every 0.15° with 2401 projections during 500ms each. After image reconstruction, visualisation are obtained from cross-sections of the hemodialyzer. Open fibers are counted with an open source computer program used for biological image analysis. By comparing the number of open fibers with the total number of fibers in an unused hemodialyzer, the percentage of open fibers can be quantified.

During the same week of the first test moment, several validated questionnaires will be completed: questionnaires about intention for bleeding (i.e. the International Society of Thrombosis and Haemostasis (ISHT) Bleeding Assessment Tool and the Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly (HASBLED) score), and a questionnaire about quality of life (i.e. EuroQoL 5D (EQ5D)). Besides, a visual inspection is performed of the limbs of the patient in order to quantify bruising.

By comparing the percentage of open fibers with the administered anticoagulation dosis and the different questionnaires about bleeding, mutual relations can be drawn.

In order to check reliability, questionnaires and visual inspection are repeated after 4 weeks and 8 weeks (test moments 2 and 3).

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Stable chronic hemodialysis patients

Description

Inclusion Criteria:

• treated with chronic daytime hemodialysis

Exclusion Criteria:

• no active infection at the time of inclusion

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relation between anticoagulation dose and number of patent dialyzer fibers	By comparing the anticoagulation dose with the number of patent fibers as measured post dialysis by visualising the dialyzer in a micro computed tomography (CT) machine and by counting the number of open fibers in a cross-section at the dialyzer outlet.	8 weeks
Relation between anticoagulation dose and bleeding score	Two validated questionnaires about bleeding are used: International Society on Thrombosis and Hemostasis Bleeding Assessment Tool (ISTH BAT) and the Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol (HASBLED). ISTH BAT score can be 0-56, with a score >4 (male) and >6 (female) to be considered as abnormal. HASBLED score can be 0-9 with a score >2 to be considered as a patient with high risk of bleeding. Scores are related to the administered anticoagulation dose.	8 weeks
Relation between bleeding score and quality of life score	Scores of the validated questionnaires about bleeding are related to the EuroQol Five Dimensions questionnaire (EQ5D) about quality of life. Scores per question are 1 to 3. Analysis is done with an online system accounting for patient's age.	8 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2022
• Primary Completion (Actual): July 10, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Bleeding; Hemodialyzer; Fibre Clotting; Bruising
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: UGent_ClotSigns

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No