Coupling Between Clotting Characteristics in Chronic Hemodialysis Patients and the Hemodialyzer Patency

NCT05440201 | Completed

• 1 other identifier: UGent_ClotPara
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Twenty stable chronic hemodialysis patients are included and will undergo one, two, three or four midweek test dialysis sessions, depending on a flow chart to follow. All patients are started (week 1) with an anticoagulant Clexane 50IE/kg and are dialyzed with their regular dialyzer and dialysis machine. Depending on the results of measured clotting characteristics and of the dialyzer scanning (i.e. percentage open fibers), it is decided (via the flow chart) whether the patient gets a second session (and so on) with an adapted anticoagulation therapy to ameliorate fiber patency while limiting bleedings.

Conditions

Bleeding; Coagulation

Outcome Measures

Primary Outcomes (1)

• Dialyzer fiber patency

  Percentage of open fibers in de dialyzer post dialysis

  4 midweek sessions

Study Arms (4)

First test session

EXPERIMENTAL

For each patient, the anticoagulant Clexane 50IE/kg is administered in the venous line of the dialysis circuit once blood is detected by the dialysis machine.

Other: Amount of anticoagulant Clexane

Second test session

EXPERIMENTAL

The dosis of Clexane is lowered or increased by 50%, depending on the results of the fiber patency and clotting characteristics of the previous session.

Other: Amount of anticoagulant Clexane

Third test session

EXPERIMENTAL

The dosis of Clexane is lowered or increased by 50%, depending on the results of the fiber patency and clotting characteristics of the previous session.

Other: Amount of anticoagulant Clexane

Fourth test session

EXPERIMENTAL

The dosis of Clexane is lowered or increased by 50%, depending on the results of the fiber patency and clotting characteristics of the previous session.

Other: Amount of anticoagulant Clexane

Interventions

Amount of anticoagulant Clexane OTHER

Change (increase/decrease) the amount of Clexane administered at the dialysis start.

First test session; Fourth test session; Second test session; Third test session

Eligibility Criteria

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

You may qualify if:

• chronic hemodialysis patients
• well functioning vascular access
• hematocrit higher than 30%

You may not qualify if:

• known heparin allergy
• severe thrombocytopenia (platelets more than 50.000/µL)
• active infection
• treatment with vitamin K antagonists

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Hemorrhage; Thrombosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Wim Van Biesen, Prof dr

  UZ Gent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: April 19, 2023
• Primary Completion: May 20, 2023
• Study Completion: May 20, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)