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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02957877
Other study ID # 2015.415
Secondary ID
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


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
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