Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

LMWH Infusion as Anticoagulation for Home HD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02957877
Recruitment Status : Unknown
Verified November 2016 by Steve Siu-Man Wong, Alice Ho Miu Ling Nethersole Hospital.
Recruitment status was:  Recruiting
First Posted : November 8, 2016
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Steve Siu-Man Wong, Alice Ho Miu Ling Nethersole Hospital

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.

Condition or disease Intervention/treatment Phase
Endstage Renal Disease Drug: Nadroparin Drug: Unfractionated heparin Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low-molecular Heparin Infusion as Anticoagulation for Nocturnal Home Hemodialysis
Study Start Date : March 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


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
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.
Other Name: Fraxiparine

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
Drug: 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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957877


Contacts
Layout table for location contacts
Contact: Steve Siu-Man Wong, MBChB, FRCPC (852) 26892000 stevesmwong@gmail.com

Locations
Layout table for location information
Hong Kong
Alice Ho Miu Ling Nethersole Hospital Recruiting
Hong Kong, Hong Kong
Contact: Steve Siu-Man Wong, MBChB, FRCPC    (852) 26892000    stevesmwong@gmail.com   
Sponsors and Collaborators
Alice Ho Miu Ling Nethersole Hospital
Investigators
Layout table for investigator information
Principal Investigator: Steve Siu-Man Wong, MBChB, FRCPC Alice Ho Miu Ling Nethersole Hospital

Layout table for additonal information
Responsible Party: Steve Siu-Man Wong, Associate Consultant, Alice Ho Miu Ling Nethersole Hospital
ClinicalTrials.gov Identifier: NCT02957877     History of Changes
Other Study ID Numbers: 2015.415
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Steve Siu-Man Wong, Alice Ho Miu Ling Nethersole Hospital:
Anticoagulation
Anti-Xa activity
Low-molecular weight heparin
Unfractionated heparin
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Nadroparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action