The Use of Low Molecular Weight Heparin in Hemodiafiltration

Chronic Kidney Disease Clinical Trial

Official title:

The Use of Low Molecular Weight Heparin in Hemodiafiltration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756145
• Other study ID #: 2008/421
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2008
• Last updated: May 13, 2015
• Start date: September 2008
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Procedure:
• At start of the session, at the inlet line
Injection of LMWH at the inlet line, at the start of the hemodiafiltration session
• 5 minutes after the start of the session, at the inlet line
Injection of LMWH at the inlet line, 5 minutes after the start of the hemodiafiltration session
• At the start of the session, at the outlet line
Injection of LMWH at the outlet line, at the start of the hemodiafiltration session

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Xa activity at the end of the session		240 min after start	No
Secondary	Anti-Xa activity during the session		at start, 30 min, 120 min and 180 min	No
Secondary	ETP during the session		at start, 30 min, 120 min, 180 min and 240 min	No
Secondary	Reduction ratio of urea		after 10min, 180min and 240min	No
Secondary	Reduction ratio of beta2microglobulin		after 10min, 180min and 240min	No
Secondary	Visual inspection of membrane and circuit		After the hemodiafiltration session	No
Secondary	pressure measurements along the circuit	inlet blood line, prefilter, transmembrane, outlet blood line	during the session	No

External Links

•   Website of the University Hospital Ghent