Low Molecular Weight Heparin for Hemodialysis Anticoagulation

This study has been completed.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01356615
First received: April 15, 2011
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

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 Intervention
End Stage Renal Failure on Dialysis
Drug: low molecular weight heparin (enoxaparin sodium)
Drug: standard unfractionated heparin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Low Molecular Weight Heparin (Enoxaparin Sodium) and Standard Unfractionated Heparin for Hemodialysis Anticoagulation

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Fibrin/clot formation in the dialyzer and Hemorrhage in Dialysis by visual inspection [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]

    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. [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 27
Study Start Date: March 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Mahboob Lessan-Pezeshki, Department of Nephrology and Dialysis, Imam Khomeini Hospital. Tehran University of Medical Sciences, Tehran, Iran
ClinicalTrials.gov Identifier: NCT01356615     History of Changes
Other Study ID Numbers: 814, enoxaparin sodium and UFH
Study First Received: April 15, 2011
Last Updated: May 18, 2011
Health Authority: 1. Iran: Department of Nephrology and Dialysis, Imam Khomeini Hospital. Tehran University of Medical Sciences, Tehran.
2. Iran: Department of Nephrology and Dialysis, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran.
3. Iran: Research Deputy of Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran.

Keywords provided by Tehran University of Medical Sciences:
anticoagulation
hemodialysis
heparin
lipids
low molecular weight heparins

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Calcium heparin
Dalteparin
Enoxaparin
Heparin
Heparin, Low-Molecular-Weight
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014