The Use of Low Molecular Weight Heparin in Hemodiafiltration

Study Overview
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Brief Summary
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Low molecular weight heparin (LMWH) is injected in the dialysis circuit at the start of the session. In the present study we compare 3 different methods of injection of LMWH: parameters of dialysis efficiency and clotting are measured. The study lasts 3 sessions for each patient.

Official Title
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The Use of Low Molecular Weight Heparin in Hemodiafiltration

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Procedure: At start of the session, at the inlet line
* Procedure: 5 minutes after the start of the session, at the inlet line
* Procedure: At the start of the session, at the outlet line


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic kidney disease stade V treated with hemodiafiltration age >18 year Hematocrit > 30% Exclusion Criteria: treatment with vitamin K antagonists treatment with other anti-coagulants or heparin besides the heparin used during dialysis active bleeding, infection or malignancy heparin associated allergy hepatic failure trombocytopenia < 120.000/µl

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Injection of LMWH at the start of the hemodiafiltration session, at the inlet bloodline | Procedure: At start of the session, at the inlet line<br>* Injection of LMWH at the inlet line, at the start of the hemodiafiltration session<br>|
| Experimental: 2<br>Injection of LMWH 5 minutes after the start of the hemodiafiltration session, at the inlet bloodline | Procedure: 5 minutes after the start of the session, at the inlet line<br>* Injection of LMWH at the inlet line, 5 minutes after the start of the hemodiafiltration session<br>|
| Experimental: 3<br>Injection of LMWH at the start of the hemodiafiltration session, at the outline bloodline | Procedure: At the start of the session, at the outlet line<br>* Injection of LMWH at the outlet line, at the start of the hemodiafiltration session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Xa activity at the end of the session |  | 240 min after start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Xa activity during the session |  | at start, 30 min, 120 min and 180 min | 
| ETP during the session |  | at start, 30 min, 120 min, 180 min and 240 min | 
| Reduction ratio of urea |  | after 10min, 180min and 240min | 
| Reduction ratio of beta2microglobulin |  | after 10min, 180min and 240min | 
| Visual inspection of membrane and circuit |  | After the hemodiafiltration session | 
| pressure measurements along the circuit | inlet blood line, prefilter, transmembrane, outlet blood line | during the session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage V, treated, hemodiafiltration