Clinical trial NCT00347490: HENOX: Enoxaparine in Hemodialysis
Official title: Efficacy and Safety in Hemodialysis With Enoxaparine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodialysis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Rate of fibrin / clot formation in dialyser and line grade in 10-point scale
Secondary outcomes:
measure: Adverse events
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Sompob Paibulsirijit
role: STUDY_DIRECTOR
References: