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

NCT ID: NCT05365542

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-27
• Study Completion Date: 2022-12-31

Brief Summary

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.

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).

Conditions

Blood Coagulation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Hemodialyzer scanning

After the hemodialysis session, the used dialyzer is rinsed and dried before scanning in a Micro Computed Tomography scanner. From cross-sectional images, the number of patent fibers is quantified.

Intervention Type: OTHER

Bleeding Questionnaires

The ISTH Bleeding Assessment Tool and the HASBLED questionnaires are asked

Intervention Type: OTHER

Quality of life questionnaire

The EQ5D questionnaire is asked.

Intervention Type: OTHER

Visual inspection of the limbs

Visual inspection is done of the patient's limbs in order to quantify bruising.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• treated with chronic daytime hemodialysis

Exclusion Criteria

• no active infection at the time of inclusion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wim Van Biesen

Role: PRINCIPAL_INVESTIGATOR

UZ Gent

Locations

Ghent University Hospital

Ghent, , Belgium

Countries

Belgium

Other Identifiers

UGent_ClotSigns

Identifier Type: -

Identifier Source: org_study_id