Low Molecular Weight Heparin for Hemodialysis Anticoagulation

Not Applicable

Completed

• Conditions: End Stage Renal Failure on Dialysis
• Interventions: Drug: low molecular weight heparin (enoxaparin sodium); Drug: standard unfractionated heparin

• Registration Number: NCT01356615
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Low-molecular weight heparins (LMWHs) as well as Unfractionated heparin (UFH) is used as anticoagulation during hemodialysis (HD) therapy. In this study the investigators have compared clinical efficacy and safety of LMWH and UFH, and their effect on lipid profile.

Detailed Description

In this prospective, randomized, cross-over study the investigators compared the safety, clinical efficacy of Clexane (enoxaparin sodium; Sanofi-Aventis) with unfractionated heparin in 27 chronic HD patients. Group A received Clexane (enoxaparin sodium; Sanofi-Aventis) and were followed up for 3 months and then crossed over to Unfractionated heparin for a further 3-month period. Group B received Unfractionated heparin first and then crossed over to Clexane, each followed up for 3 months. Heparin anticoagulation, clinical clotting and hemorrhage were evaluated by visual inspection after blood draining of the air trap.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2011-04-15
• Status Verified: 2011-05
• Study First Submitted QC: 2011-05-18
• Last Update Submitted: 2011-05-18
• Study First Posted: 2011-05-19
• Last Update Posted: 2011-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• patients in end stage renal failure requiring maintenance dialysis were recruited into the study

Exclusion Criteria

• Patients with known bleeding disorders
• Subjects receiving oral or other forms of anticoagulant therapy (e.g. warfarin, aspirin) or drugs that could affect heparin activity (e.g. digitalis, tetracyclines, and antihistamines) were also excluded. Subjects continued their usual medication (including lipid-lowering therapy ) and were treated in the normal manner by their caring physicians during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
enoxaparin	low molecular weight heparin (enoxaparin sodium)	enoxaparin sodium (Clexane) (40 mg) followed prospectively for 3 months (36 dialyses)
standard unfractionated heparin	standard unfractionated heparin	standard unfractionated heparin followed prospectively for 3 months (36 dialyses)

Primary Outcome Measures

Name	Time	Method
Fibrin/clot formation in the dialyzer and Hemorrhage in Dialysis by visual inspection	3 month	The frequency and degree of clot and fibrin formation in both the dialyzer and lines were scored on a 10-point scale, with 1 indicating no clot formation and 10 sever clotting or total occlusion. This assessment was done after the blood had been returned to the patient by flushing the dialyzer and lines with normal saline. Hemorrhage or thrombosis, during and between dialyses was also noted. Heparin anticoagulation, Clinical clotting and Hemorrhage were evaluated by visual inspection.; Hemorrhages were categorized as weak, moderate, and severe.

Secondary Outcome Measures

Name	Time	Method
changes in serum Cholesterol,low and High Density Lipoprotein and Triglycerid.	3 month	27 chronic HD patients. They were randomly assigned to either Clexane (40 mg) or standard heparin, and followed prospectively for 3 months (36 dialyses) and then crossed over to the alternate therapy for a further 3 months Fasting standard lipid profiles were determined at the end of each arm of the study. Total cholesterol (TC), high density lipoprotein (HDL), and triglyceride (TG) were measured.