search
Back to results

LMWH Infusion as Anticoagulation for Home HD

Primary Purpose

Endstage Renal Disease

Status
Unknown status
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Nadroparin
Unfractionated heparin
Sponsored by
Alice Ho Miu Ling Nethersole Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endstage Renal Disease focused on measuring Anticoagulation, Anti-Xa activity, Low-molecular weight heparin, Unfractionated heparin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alice Ho Miu Ling Nethersole HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LMWH arm

UFH arm

Arm Description

8-hour hemodialysis is performed on alternate day for a week at the dialysis unit (i.e. 3 sessions) by using low-molecular weight heparin (nadroparin) as anticoagulation

8-hour hemodialysis is performed on alternate day for a week at the dialysis unit (i.e. 3 sessions) by using unfractionated heparin as anticoagulation

Outcomes

Primary Outcome Measures

Prothrombin time
Prothrombin time is monitored in both of the LMWH and UFH arms
Activated partial thromboplastin time
Activated partial thromboplastin time is monitored in both of the LMWH and UFH arms
Anti-Xa level
Anti-Xa level is only monitored in the LMWH arm
Dialyser urea and creatinine clearances
Dialyser urea and creatinine clearances are evaluated in both of the LMWH and UFH arms
Dialyser thrombus score
Dialyser thrombus score is evaluated in both of the LMWH and UFH arms

Secondary Outcome Measures

Full Information

First Posted
November 2, 2016
Last Updated
November 4, 2016
Sponsor
Alice Ho Miu Ling Nethersole Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02957877
Brief Title
LMWH Infusion as Anticoagulation for Home HD
Official Title
Low-molecular Heparin Infusion as Anticoagulation for Nocturnal Home Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alice Ho Miu Ling Nethersole Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endstage Renal Disease
Keywords
Anticoagulation, Anti-Xa activity, Low-molecular weight heparin, Unfractionated heparin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LMWH arm
Arm Type
Experimental
Arm Description
8-hour hemodialysis is performed on alternate day for a week at the dialysis unit (i.e. 3 sessions) by using low-molecular weight heparin (nadroparin) as anticoagulation
Arm Title
UFH arm
Arm Type
Active Comparator
Arm Description
8-hour hemodialysis is performed on alternate day for a week at the dialysis unit (i.e. 3 sessions) by using unfractionated heparin as anticoagulation
Intervention Type
Drug
Intervention Name(s)
Nadroparin
Other Intervention Name(s)
Fraxiparine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Unfractionated heparin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prothrombin time
Description
Prothrombin time is monitored in both of the LMWH and UFH arms
Time Frame
Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis
Title
Activated partial thromboplastin time
Description
Activated partial thromboplastin time is monitored in both of the LMWH and UFH arms
Time Frame
Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis
Title
Anti-Xa level
Description
Anti-Xa level is only monitored in the LMWH arm
Time Frame
Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis; 24 hours after administration of LMWH
Title
Dialyser urea and creatinine clearances
Description
Dialyser urea and creatinine clearances are evaluated in both of the LMWH and UFH arms
Time Frame
At 15 mins after starting hemodialysis and 15 mins before the end of hemodialysis
Title
Dialyser thrombus score
Description
Dialyser thrombus score is evaluated in both of the LMWH and UFH arms
Time Frame
At the end of hemodialysis (8th hour)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steve Siu-Man Wong, MBChB, FRCPC
Phone
(852) 26892000
Email
stevesmwong@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Siu-Man Wong, MBChB, FRCPC
Organizational Affiliation
Alice Ho Miu Ling Nethersole Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve Siu-Man Wong, MBChB, FRCPC
Phone
(852) 26892000
Email
stevesmwong@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

LMWH Infusion as Anticoagulation for Home HD

We'll reach out to this number within 24 hrs