HENOX: Enoxaparine in Hemodialysis

NCT00347490 | Completed Phase 4

• 1 other identifier: ENOXA_L_00821
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• Adverse events

Interventions

Enoxaparine DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Bangkok, Thailand

Location

MeSH Terms

Interventions

Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Sompob Paibulsirijit

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 4, 2006
• Study Start: May 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: June 1, 2007
• Last Updated: January 24, 2008

Record last verified: 2008-01

Locations

TH (1)