HENOX: Enoxaparine in Hemodialysis

NCT ID: NCT00347490

Last Updated: 2008-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2007-06-30

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

Conditions

Hemodialysis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Enoxaparine

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Principal Investigators

Sompob Paibulsirijit

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

ENOXA_L_00821

Identifier Type: -

Identifier Source: org_study_id