HENOX: Enoxaparine in Hemodialysis

Study Overview
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Brief Summary
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Primary objective: To assess clinical efficacy of single bolus anticoagulation with Enoxaparin in chronic hemodialysis Secondary objective: To assess safety and tolerability by the number of spontaneously reported adverse events by patients

Official Title
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Efficacy and Safety in Hemodialysis With Enoxaparine

Conditions
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Hemodialysis

Intervention / Treatment
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* Drug: Enoxaparine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: End stage renal failure requiring maintenance hemodialysis at least twice a week Has arterio-venous fistula or arterio-venous graft in upper extremities which can apply to blood flow > or = 250ml/min as a vascular access for hemodialysis. Stable hemodialysis prescription at least 1 month before enrollment UFH (Unfractionated Heparin) was prescribed as an anticoagulant in the previous hemodialysis prescription No sign of active infection . Absence of recent cardiovascular complication such as myocardial infarction, DVT (Deep Venous Thrombosis), arterial occlusion, pulmonary embolism, cerebrovascular disease in previous 3 months. Exclusion Criteria: Women who are breastfeeding, pregnant or of childbearing age and not using medically acceptable effective contraception Patients with any evidence of an active bleeding disorder Contraindication to anticoagulation: Prior history of cerebral hemorrhage at any time Coagulopathy (acquired or inherited) Recent surgery Major surgery such as neurosurgery within the past 3 months Minor surgery such as intraocular surgery within 1 month. Uncontrolled predialytic arterial hypertension (systolic BP > 200 mmHg or diastolic BP > 110 mmHg) at 2 successive readings Impaired hemostasis i.e., known or suspected coagulopathy (acquired or inherited): baseline platelet count <100,000/mm3 in patients without baseline diagnosis of active cancer and undergoing chemotherapy treatment (for patients with diagnosis of cancer and undergoing chemotherapy, baseline platelet count >70,000/mm3); aPTT (activated Partial Thromboplastin Time) 1.5X the laboratory upper limit of normal; or international normalized ratio (INR) >1.5 Indication for thrombolytic therapy such as ischemic heart disease, ischemic stroke. Need for a curative treatment of anticoagulant therapy(DVT ,pulmonary embolism, ischemic heart disease) Patients treated with oral anticoagulant therapy within 72 hours prior to inclusion Patients who have had spinal or epidural analgesia or lumbar puncture within the preceding 24 hours Abnormal liver enzyme and total bilirubin within 2 weeks (SGPT, SGOT, total bilirubin above 2 times of Upper normal limit) Known hypersensitivity to heparin or LMWH (Low Molecular Weight Heparin), or pork derived products History of documented episode of heparin or LMWH induced thrombocytopenia and/or thrombosis. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enoxaparine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of fibrin / clot formation in dialyser and line grade in 10-point scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  |