HENOX: Enoxaparine in Hemodialysis

Sanofi

Status and phase

Completed

Phase 4

Conditions

Hemodialysis

Treatments

Drug: Enoxaparine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00347490

ENOXA_L_00821

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.