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

NCT05365542 | Completed DMC

• 1 other identifier: UGent_ClotSigns
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Coagulation

Keywords

Hemodialyzer; Fibre Clotting; Quality of life; Bleeding; Bruising

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Hemodialyzer scanning OTHER

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.

Bleeding Questionnaires OTHER

The ISTH Bleeding Assessment Tool and the HASBLED questionnaires are asked

Quality of life questionnaire OTHER

The EQ5D questionnaire is asked.

Visual inspection of the limbs OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stable chronic hemodialysis patients

You may qualify if:

• treated with chronic daytime hemodialysis

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Thrombosis; Hemorrhage; Contusions

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds, Nonpenetrating; Wounds and Injuries

Study Officials

• Wim Van Biesen

  UZ Gent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: May 9, 2022
• Study Start: April 27, 2022
• Primary Completion: July 10, 2022
• Study Completion: December 31, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

BE (1)