- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02957877
LMWH Infusion as Anticoagulation for Home HD
November 4, 2016 updated by: Steve Siu-Man Wong, Alice Ho Miu Ling Nethersole Hospital
Low-molecular Heparin Infusion as Anticoagulation for Nocturnal Home Hemodialysis
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.
Study Overview
Status
Unknown
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Steve Siu-Man Wong, MBChB, FRCPC
- Phone Number: (852) 26892000
- Email: stevesmwong@gmail.com
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- Alice Ho Miu Ling Nethersole Hospital
-
Contact:
- Steve Siu-Man Wong, MBChB, FRCPC
- Phone Number: (852) 26892000
- Email: stevesmwong@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LMWH arm
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
|
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.
Other Names:
|
Active Comparator: UFH arm
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prothrombin time
Time Frame: Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis
|
Prothrombin time is monitored in both of the LMWH and UFH arms
|
Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis
|
Activated partial thromboplastin time
Time Frame: Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis
|
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
|
Anti-Xa level
Time Frame: Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis; 24 hours after administration of LMWH
|
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
|
Dialyser urea and creatinine clearances
Time Frame: At 15 mins after starting hemodialysis and 15 mins before the end of hemodialysis
|
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
|
Dialyser thrombus score
Time Frame: At the end of hemodialysis (8th hour)
|
Dialyser thrombus score is evaluated in both of the LMWH and UFH arms
|
At the end of hemodialysis (8th hour)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Steve Siu-Man Wong, MBChB, FRCPC, Alice Ho Miu Ling Nethersole Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Anticipated)
May 1, 2018
Study Completion (Anticipated)
May 1, 2018
Study Registration Dates
First Submitted
November 2, 2016
First Submitted That Met QC Criteria
November 4, 2016
First Posted (Estimate)
November 8, 2016
Study Record Updates
Last Update Posted (Estimate)
November 8, 2016
Last Update Submitted That Met QC Criteria
November 4, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015.415
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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