Hôpital de la Conception
Marseille, Bouches du Rhône, 13885, France
Location status: Recruiting
Location contact
Thomas Robert, MD, PhD
CONTACT
NCT Number: NCT06224140
Intermittent hemodialysis is a complex technique which requires careful monitoring of anticoagulation levels to prevent clotting and reduce the risk of bleeding complications. Dialysis patients often exhibit hypercoagulable tendencies due to uremic state, turbulent blood flows in dialysis procedures, and thrombogenic exposure to artificial surfaces of dialysis tubing. Patients with ESRD may experience both dialyzer clotting and excessive bleeding, so individualized heparin dosing and periodic adjustments are necessary to ensure adequate anticoagulation during hemodialysis. The ideal anticoagulant should prevent thrombosis while minimizing the risk of intra- and interdialytic bleeding. The use of heparin carries risks such as worsening of osteoporosis and dyslipidemia, allergic reactions like pruritus, and the potential for life-threatening heparin-induced thrombocytopenia (HIT) for which avoidance of heparin is necessary during dialysis.Heparin, in both its unfractionated heparin (UFH) and low molecular weight heparin (LMWH) forms, is the most commonly used anticoagulant, though evidence comparing their efficacy and risk of bleeding remains inconclusive. End-stage renal disease (ESRD) patients, who are already at higher risk of serious bleeding, may benefit from regional anticoagulation (RA) techniques, as they typically receive around 600,000 IU of heparin per year. The investigators performed routinely a simplified regional anticoagulation procedure (RAP) using a constant calcium re-injection rate over the time to avoid hypocalcemia. This procedure eliminates the need for citrate infusion and calcium monitoring, and reduces nurse workload in a chronic dialysis unit. The investigators compared 21 chronic dialysis patients with 198 RA and 195 heparin sessions, where each patient acted as their own control. None of them were on VKA during the RA sessions, 62% were on single anti-platelet therapy and 14% were on dual anti-platelet therapy. The dialysis session success rate was 94% in the RA group and 97% in the heparin group, with no significant differences (p=0.22). The circuit loss rate was 1.5% per RA session and 0.5% per heparin session (p=0.23), and the early blood restitution rate was 3% and 1.5% (p=0.50) in the RA and heparin groups, respectively
Hypothesis: RAP can be as effective as systemic anticoagulation with heparin for intermittent dialysis in chronic hemodialysis patients, with the potential to reduce the rate of hemorrhagic events
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Marseille, Bouches du Rhône, 13885, France
Location status: Recruiting
Thomas Robert, MD, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Conventional dialysis with heparin as anticoagulant treatment
Dialysis without heparin as anticoagulant but based on the use of a calcium-free dialysis bath. Calcium is then restored by reinjection of a 10% calcium chloride solution.
Time frame: 6 months
The primary endpoint will be the rate of dialysis sessions success over 6 months between two therapeutic strategies:
Time frame: 6 months
Rate of bypass loss
Time frame: 6 months
Rate of early bypass restitution (defined as a restitution 30 minutes or more before the end of the prescribed time)
Time frame: 6 months
Mean difference of dialysis duration over 6 month between the groups
Time frame: 6 months
Rate of fistula compression time extended more than 10 minutes after a dialysis session
Time frame: 6 months
Incidence rate of hemorrhagic events
Time frame: 6 months
Time average-dialysis adequacy difference defined by the average kt/v over 6 months
Time frame: 6 months
Mean difference at months +6 and time-average evolution over 6 month for calcium, phosphor, bone-specific alkaline phosphatase and parathyroid hormone concentration between the groups
Time frame: 6 months
Rate of hyperparathyroidism defined par PTH > 9N at month +6
Time frame: 6 months
Rate of non-hemorrhagic heparin-related complications:
Time frame: 6 months
Incidence rate of MACE at months +6
Time frame: 6 months
All-cause mortality rate at month +6
Time frame: 6 months
Rate of per-dialytic hypotension over 6 months
Time frame: 6 months
Rate of adverse events over 6 months
Contact information is provided by the study sponsor or research team.
Assistance Publique Hopitaux De Marseille
Other
Acronym: HepFreeHD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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