HENOX: Enoxaparine in Hemodialysis

Hemodialysis Clinical Trial

Official title:

Efficacy and Safety in Hemodialysis With Enoxaparine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347490
• Other study ID #: ENOXA_L_00821
• Status: Completed
• Phase: Phase 4
• First received: June 30, 2006
• Last updated: January 22, 2008
• Start date: May 2006
• Est. completion date: June 2007

Study information

• Verified date: January 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis

Intervention

Drug:
• Enoxaparine

Locations

Country	Name	City	State
Thailand	Sanofi-Aventis	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of fibrin / clot formation in dialyser and line grade in 10-point scale
Secondary	Adverse events