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HENOX: Enoxaparine in Hemodialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00347490
First Posted: July 4, 2006
Last Update Posted: January 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347490


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

ClinicalTrials.gov Identifier: NCT00347490     History of Changes
Other Study ID Numbers: ENOXA_L_00821
First Submitted: June 30, 2006
First Posted: July 4, 2006
Last Update Posted: January 24, 2008
Last Verified: January 2008