Hemodialysis
Conditions
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
Interventions
DRUGEnoxaparine
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of fibrin / clot formation in dialyser and line grade in 10-point scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Countries
Thailand
Outcome results
None listed