search
Back to results

Low Molecular Weight Heparin for Hemodialysis Anticoagulation

Primary Purpose

End Stage Renal Failure on Dialysis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
low molecular weight heparin (enoxaparin sodium)
standard unfractionated heparin
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for End Stage Renal Failure on Dialysis focused on measuring anticoagulation, hemodialysis, heparin, lipids, low molecular weight heparins

Eligibility Criteria

25 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    enoxaparin

    standard unfractionated heparin

    Arm Description

    enoxaparin sodium (Clexane) (40 mg) followed prospectively for 3 months (36 dialyses)

    standard unfractionated heparin followed prospectively for 3 months (36 dialyses)

    Outcomes

    Primary Outcome Measures

    Fibrin/clot formation in the dialyzer and Hemorrhage in Dialysis by visual inspection
    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

    changes in serum Cholesterol,low and High Density Lipoprotein and Triglycerid.
    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.

    Full Information

    First Posted
    April 15, 2011
    Last Updated
    May 18, 2011
    Sponsor
    Tehran University of Medical Sciences
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01356615
    Brief Title
    Low Molecular Weight Heparin for Hemodialysis Anticoagulation
    Official Title
    Low Molecular Weight Heparin (Enoxaparin Sodium) and Standard Unfractionated Heparin for Hemodialysis Anticoagulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    March 2011 (Actual)
    Study Completion Date
    March 2011 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tehran University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End Stage Renal Failure on Dialysis
    Keywords
    anticoagulation, hemodialysis, heparin, lipids, low molecular weight heparins

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    enoxaparin
    Arm Type
    Experimental
    Arm Description
    enoxaparin sodium (Clexane) (40 mg) followed prospectively for 3 months (36 dialyses)
    Arm Title
    standard unfractionated heparin
    Arm Type
    Active Comparator
    Arm Description
    standard unfractionated heparin followed prospectively for 3 months (36 dialyses)
    Intervention Type
    Drug
    Intervention Name(s)
    low molecular weight heparin (enoxaparin sodium)
    Intervention Description
    Enoxaparin sodium (Clexane; 40 mg) was administered 3-4 min before dialysis as a bolus dose, into the arterial line pre-dialyzer.
    Intervention Type
    Drug
    Intervention Name(s)
    standard unfractionated heparin
    Intervention Description
    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 Measure Information:
    Title
    Fibrin/clot formation in the dialyzer and Hemorrhage in Dialysis by visual inspection
    Description
    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.
    Time Frame
    3 month
    Secondary Outcome Measure Information:
    Title
    changes in serum Cholesterol,low and High Density Lipoprotein and Triglycerid.
    Description
    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.
    Time Frame
    3 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    76 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Low Molecular Weight Heparin for Hemodialysis Anticoagulation

    We'll reach out to this number within 24 hrs