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
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, see Learn About Clinical Studies.

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 July 23, 2014