Low Molecular Weight Heparin for Hemodialysis Anticoagulation

NCT01356615 | Completed DMC

• 2 other identifiers: 814enoxaparin sodium and UFH
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

End Stage Renal Failure on Dialysis

Keywords

anticoagulation; hemodialysis; heparin; lipids; low molecular weight heparins

Outcome Measures

Primary Outcomes (1)

• 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.

  3 month

Secondary Outcomes (1)

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

  3 month

Study Arms (2)

enoxaparin

EXPERIMENTAL

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

Drug: low molecular weight heparin (enoxaparin sodium)

standard unfractionated heparin

ACTIVE COMPARATOR

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

Drug: standard unfractionated heparin

Interventions

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.

enoxaparin

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.

standard unfractionated heparin

Eligibility Criteria

• Age: 25 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients in end stage renal failure requiring maintenance dialysis were recruited into the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Related Publications (1)

• Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.

  PMID: 38189593 DERIVED

MeSH Terms

Interventions

Heparin, Low-Molecular-Weight; enoxaparin sodium

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: May 19, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 19, 2011

Record last verified: 2011-05