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Completed

NCT Number: NCT01356615

Low Molecular Weight Heparin for Hemodialysis Anticoagulation

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.

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Key information

Conditions

End Stage Renal Failure on Dialysis

Age range

25 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

low molecular weight heparin (enoxaparin sodium)

Drug

Enoxaparin sodium (Clexane; 40 mg) was administered 3-4 min before dialysis as a bolus dose, into the arterial line pre-dialyzer.

standard unfractionated heparin

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

Low Molecular Weight Heparin (Enoxaparin Sodium) and Standard Unfractionated Heparin for Hemodialysis Anticoagulation

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 19, 2011
Registry last updated
May 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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