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Low Molecular Weight Heparin for Hemodialysis Anticoagulation

T

Tehran University of Medical Sciences

Status

Completed

Conditions

End Stage Renal Failure on Dialysis

Treatments

Drug: low molecular weight heparin (enoxaparin sodium)
Drug: standard unfractionated heparin

Study type

Interventional

Funder types

Other

Identifiers

NCT01356615
814
enoxaparin sodium and UFH (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

25 to 76 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

27 participants in 2 patient groups

enoxaparin
Experimental group
Description:
enoxaparin sodium (Clexane) (40 mg) followed prospectively for 3 months (36 dialyses)
Treatment:
Drug: low molecular weight heparin (enoxaparin sodium)
standard unfractionated heparin
Active Comparator group
Description:
standard unfractionated heparin followed prospectively for 3 months (36 dialyses)
Treatment:
Drug: standard unfractionated heparin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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