HENOX: Enoxaparine in Hemodialysis

Phase 4

Completed

• Conditions: Hemodialysis

• Registration Number: NCT00347490
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-06-30
• Study First Posted: 2006-07-04
• Primary Completion: 2007-04
• Study Completion: 2007-06
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-22
• Last Update Posted: 2008-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of fibrin / clot formation in dialyser and line grade in 10-point scale

Secondary Outcome Measures

Name	Time	Method
Adverse events

Trial Locations

Locations (1)

Sanofi-Aventis; 🇹🇭 Bangkok, Thailand