LMWH Infusion as Anticoagulation for Home HD

Endstage Renal Disease Clinical Trial

Official title:

Low-molecular Heparin Infusion as Anticoagulation for Nocturnal Home Hemodialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02957877
• Other study ID #: 2015.415
• Status: Recruiting
• Phase: Phase 4
• First received: November 2, 2016
• Last updated: November 4, 2016
• Start date: March 2016
• Est. completion date: May 2018

Study information

• Verified date: November 2016
• Source: Alice Ho Miu Ling Nethersole Hospital
• Contact: Steve Siu-Man Wong, MBChB, FRCPC
• Phone: (852) 26892000
• Email: stevesmwong[@]gmail.com
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

There is a lack of data in the literature about the use of low-molecular weight heparin (LMWH) as anticoagulation for nocturnal home hemodialysis (NHHD). This study aims to evaluate the efficacy and safety of LMWH, administered by infusion method, as compared to unfractionated heparin as anticoagulation for NHHD treatment.

Description:

Low-molecular weight heparin (LMWH) and unfractionated heparin (UFH) are established systemic anticoagulants for the patients who receive conventional thrice-weekly hemodialysis in absence of significant bleeding risk. For the patients who undergo nocturnal home hemodialysis (NHHD), LMWH is seldom utilized because of the need of an additional bolus injection during a long dialysis treatment, which is impractical as the patients are sleeping during hemodialysis. Moreover, there is a potential risk of LMWH accumulation due to its longer half-life. As there is a paucity of data in the literature on the use of LMWH for NHHD treatment, this trial is conducted to assess the safety and efficacy of LMWH, administered by infusion method, in this particular group of dialysis patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prevalent NHHD patients who have received >1 year dialysis with unfractionated heparin as anticoagulant

• Age >= 18

• Informed consent available

Exclusion Criteria:

• History of intolerance to LMWHs during HD

• Receiving warfarin or other oral anticoagulant

• Pregnant patients

Study Design

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

Related Conditions & MeSH terms

• Endstage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• Nadroparin
A nadroparin infusion regimen (loading dose of 35 IU/kg, followed by 10 IU/kg per hour for 6 hours) is administered as anticoagulation during the 8-hour hemodialysis.
• Unfractionated heparin
The individualized unfractionated heparin infusion regimen currently employed by the recruited patients in their home dialysis treatment is administered as anticoagulation during the 8-hour hemodialysis.

Locations

Country	Name	City	State
Hong Kong	Alice Ho Miu Ling Nethersole Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Alice Ho Miu Ling Nethersole Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prothrombin time	Prothrombin time is monitored in both of the LMWH and UFH arms	Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis	No
Primary	Activated partial thromboplastin time	Activated partial thromboplastin time is monitored in both of the LMWH and UFH arms	Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis	No
Primary	Anti-Xa level	Anti-Xa level is only monitored in the LMWH arm	Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis; 24 hours after administration of LMWH	No
Primary	Dialyser urea and creatinine clearances	Dialyser urea and creatinine clearances are evaluated in both of the LMWH and UFH arms	At 15 mins after starting hemodialysis and 15 mins before the end of hemodialysis	No
Primary	Dialyser thrombus score	Dialyser thrombus score is evaluated in both of the LMWH and UFH arms	At the end of hemodialysis (8th hour)	No