HepFree Trial: a Study to Compare Five Different Ways of Providing Heparin-free Hemodialysis in Patients With High Risk of Bleeding

Not Applicable

Recruiting

• Conditions: Chronic Kidney Disease; End-stage renal failure; Hemodialysis; Hemodiafiltration; High risk of bleeding; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12619000416190
• Lead Sponsor: Pedro Henrique Franca Gois

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

•Individuals with end stage renal failure on maintenance HD or HDF for more than 3 months;
•In-centre dialysis; high risk of bleeding (at the discretion of the assisting renal physician);
•Native or graft arteriovenous fistula with blood flow at least 250 ml/min;
•Patients with a tunnelled catheter locked by heparin can be included in the study after removal of heparin and rinsing the catheter prior to starting the treatment;
•Minimum age of 18 years with no gender restriction.

Exclusion Criteria

•Dialysis in the intensive care unit;
•Patients with acute kidney injury;
•Patients treated in single needle mode;
•Known heparin contraindication (e.g. heparin-induced thrombocytopenia type II);
•Patients requiring blood products;
•Patients receiving oral anticoagulants (including anti-vitamin K) (> 3 days since treatment stopped and/or normalized international normalized ratio will be allowed);
•Patients receiving a combination of anti-platelet agents (> 5 days since treatment stopping will be allowed);
•Patients currently on unfractioned (UFH) or low molecular weight heparin (LMWH) for treatment of deep vein thrombosis;
•Patients treated with UFH or LMWH to prevent deep vein thrombosis (24 hours since last dose of LMWH or 12 hours since last dose of UFH was allowed).
•Patients with laboratory markers of liver dysfunction (ALT and AST more than double of upper borderline lab value);
•Patients with known coagulopathy or haemostasis disorder (pathological value of prothrombin time and aPTT, and platelets less than 50,000/ul);
•Patients with the diagnosis of malignancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
successful completion of hemodialysis or hemodiafiltration without significant problems with blood clotting. Treatments will be considered successful when there is: <br>•No complete occlusion of air traps or dialyzer rendering dialysis impossible;<br>•No additional saline flushes to prevent clotting;<br>•No change of dialyzer or bloodlines because of clotting;<br>•No premature termination (early rinse-back) because of clotting.<br>[ 4hr of hemodialysis]