The Use of Low Molecular Weight Heparin in Hemodiafiltration

Phase 4

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Procedure: At start of the session, at the inlet line; Procedure: 5 minutes after the start of the session, at the inlet line; Procedure: At the start of the session, at the outlet line

• Registration Number: NCT00756145
• Lead Sponsor: University Hospital, Ghent

Brief Summary

Low molecular weight heparin (LMWH) is injected in the dialysis circuit at the start of the session. In the present study we compare 3 different methods of injection of LMWH: parameters of dialysis efficiency and clotting are measured. The study lasts 3 sessions for each patient.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-18
• Study First Posted: 2008-09-19
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-13
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• chronic kidney disease stade V treated with hemodiafiltration
• age >18 year
• Hematocrit > 30%

Exclusion Criteria

• treatment with vitamin K antagonists
• treatment with other anti-coagulants or heparin besides the heparin used during dialysis
• active bleeding, infection or malignancy
• heparin associated allergy
• hepatic failure
• trombocytopenia < 120.000/µl

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	At start of the session, at the inlet line	Injection of LMWH at the start of the hemodiafiltration session, at the inlet bloodline
2	5 minutes after the start of the session, at the inlet line	Injection of LMWH 5 minutes after the start of the hemodiafiltration session, at the inlet bloodline
3	At the start of the session, at the outlet line	Injection of LMWH at the start of the hemodiafiltration session, at the outline bloodline

Primary Outcome Measures

Name	Time	Method
Anti-Xa activity at the end of the session	240 min after start

Secondary Outcome Measures

Name	Time	Method
pressure measurements along the circuit	during the session	inlet blood line, prefilter, transmembrane, outlet blood line
Visual inspection of membrane and circuit	After the hemodiafiltration session
Reduction ratio of beta2microglobulin	after 10min, 180min and 240min
Anti-Xa activity during the session	at start, 30 min, 120 min and 180 min
ETP during the session	at start, 30 min, 120 min, 180 min and 240 min
Reduction ratio of urea	after 10min, 180min and 240min

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium