HENOX: Enoxaparine in Hemodialysis

Launched by SANOFI · Jun 30, 2006

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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.