Status:
COMPLETED
HENOX: Enoxaparine in Hemodialysis
Lead Sponsor:
Sanofi
Conditions:
Hemodialysis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 sponta...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00347490
Start Date
May 1 2006
End Date
June 1 2007
Last Update
January 24 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis
Bangkok, Thailand