NCT02957877

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

2.2 years

First QC Date

November 2, 2016

Last Update Submit

November 4, 2016

Conditions

Endstage Renal Disease

Keywords

AnticoagulationAnti-Xa activityLow-molecular weight heparinUnfractionated heparin

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • Dialyser thrombus score

    Dialyser thrombus score is evaluated in both of the LMWH and UFH arms

    At the end of hemodialysis (8th hour)

Study Arms (2)

LMWH arm

EXPERIMENTAL

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

UFH arm

ACTIVE COMPARATOR

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

Interventions

NadroparinDRUG

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.

Also known as: Fraxiparine
LMWH arm
Unfractionated heparinDRUG

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.

UFH arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prevalent NHHD patients who have received \>1 year dialysis with unfractionated heparin as anticoagulant
  • Age \>= 18
  • Informed consent available

You may not qualify if:

  • History of intolerance to LMWHs during HD
  • Receiving warfarin or other oral anticoagulant
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alice Ho Miu Ling Nethersole Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.

    PMID: 38189593DERIVED

MeSH Terms

Interventions

NadroparinHeparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Steve Siu-Man Wong, MBChB, FRCPC

    Alice Ho Miu Ling Nethersole Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steve Siu-Man Wong, MBChB, FRCPC

CONTACT

(852) 26892000stevesmwong@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 8, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

November 8, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)