HENOX: Enoxaparine in Hemodialysis

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00347490
First received: June 30, 2006
Last updated: January 22, 2008
Last verified: January 2008
  Purpose

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


Condition Intervention Phase
Hemodialysis
Drug: Enoxaparine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety in Hemodialysis With Enoxaparine

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Rate of fibrin / clot formation in dialyser and line grade in 10-point scale

Secondary Outcome Measures:
  • Adverse events

Estimated Enrollment: 100
Study Start Date: May 2006
Study Completion Date: June 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347490

Locations
Thailand
Sanofi-Aventis
Bangkok, Thailand
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Sompob Paibulsirijit Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00347490     History of Changes
Other Study ID Numbers: ENOXA_L_00821
Study First Received: June 30, 2006
Last Updated: January 22, 2008
Health Authority: Thailand: Ministry of Public Health

Additional relevant MeSH terms:
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014