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Trial record 63 of 989 for:    Heparin sodium

Low Molecular Weight Heparin for Hemodialysis Anticoagulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01356615
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : May 19, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
End Stage Renal Failure on Dialysis Drug: low molecular weight heparin (enoxaparin sodium) Drug: standard unfractionated heparin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Low Molecular Weight Heparin (Enoxaparin Sodium) and Standard Unfractionated Heparin for Hemodialysis Anticoagulation
Study Start Date : March 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: enoxaparin
enoxaparin sodium (Clexane) (40 mg) followed prospectively for 3 months (36 dialyses)
Drug: low molecular weight heparin (enoxaparin sodium)
Enoxaparin sodium (Clexane; 40 mg) was administered 3-4 min before dialysis as a bolus dose, into the arterial line pre-dialyzer.

Active Comparator: standard unfractionated heparin
standard unfractionated heparin followed prospectively for 3 months (36 dialyses)
Drug: standard unfractionated heparin
Heparin (sodium heparin 5000 IU/ml) was administered as a bolus dose (50 IU/kg body weight) intravenously into the pre-dialyzer arterial line of the extracorporeal blood circuit, followed by a maintenance dose of 1000 IU sodium heparin per hour.

Primary Outcome Measures :
  1. Fibrin/clot formation in the dialyzer and Hemorrhage in Dialysis by visual inspection [ Time Frame: 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 :
  1. changes in serum Cholesterol,low and High Density Lipoprotein and Triglycerid. [ Time Frame: 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.

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Ages Eligible for Study:   25 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Responsible Party: Mahboob Lessan-Pezeshki, Department of Nephrology and Dialysis, Imam Khomeini Hospital. Tehran University of Medical Sciences, Tehran, Iran Identifier: NCT01356615     History of Changes
Other Study ID Numbers: 814
enoxaparin sodium and UFH ( Other Identifier: Tehran University of Medical Sciences )
First Posted: May 19, 2011    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: May 2011

Keywords provided by Tehran University of Medical Sciences:
low molecular weight heparins

Additional relevant MeSH terms:
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Calcium heparin
Heparin, Low-Molecular-Weight
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action