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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heparin Anticoagulation | Active Comparator |
| |
| Regional Anticoagulation Procedure (RAP) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin Anticoagulation | Procedure | Conventional dialysis with heparin as anticoagulant treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate the non-inferiority of the regional anticoagulation procedure compared to heparin anticoagulation on the dialysis sessions success three times per week | The primary endpoint will be the rate of dialysis sessions success over 6 months between two therapeutic strategies:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compare between the groups clinical Impact at each dialyses session on bypass loss | Rate of bypass loss | 6 months |
| Compare between the groups clinical Impact at each dialyses session on early bypass restitution |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Robert | Contact | 04 91 38 41 17 | +33 | thomas.robert@ap-hm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Conception | Recruiting | Marseille | Bouches du Rhône | 13885 | France |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Regional Anticoagulation Procedure (RAP) | Procedure | 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. |
|
Rate of early bypass restitution (defined as a restitution 30 minutes or more before the end of the prescribed time)
| 6 months |
| Compare between the groups clinical Impact at each dialyses session on dialysis duration | Mean difference of dialysis duration over 6 month between the groups | 6 months |
| Compare between the groups clinical Impact at each dialyses session on fistula compression time extended more than 10 minutes | Rate of fistula compression time extended more than 10 minutes after a dialysis session | 6 months |
| Compare between the groups clinical Impact during the total duration of the study on incidence of hemorrhagic events | Incidence rate of hemorrhagic events | 6 months |
| Compare between the groups clinical Impact during the total duration of the study on dialysis adequacy | Time average-dialysis adequacy difference defined by the average kt/v over 6 months | 6 months |
| Compare between the groups clinical Impact during the total duration of the study on relative effects on phosphocalcic balance | 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 | 6 months |
| Compare between the groups clinical Impact during the total duration of the study on incidence of Hyperparthyroidism | Rate of hyperparathyroidism defined par PTH > 9N at month +6 | 6 months |
| Compare between the groups clinical Impact during the total duration of the study on incidence of non-hemorrhagic heparin-related complications | Rate of non-hemorrhagic heparin-related complications:
| 6 months |
| Compare between the groups clinical Impact during the total duration of the study on incidence of cardiovascular-related mortality and major cardiovascular events (MACE) | Incidence rate of MACE at months +6 | 6 months |
| Compare between the groups clinical Impact during the total duration of the study on global mortality | All-cause mortality rate at month +6 | 6 months |
| Compare between the groups the tolerance of per-dialytic hypotension | Rate of per-dialytic hypotension over 6 months | 6 months |
| Compare between the groups the tolerance of adverse events | Rate of adverse events over 6 months | 6 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |