LMWH Infusion as Anticoagulation for Home HD

Sponsor

Alice Ho Miu Ling Nethersole Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02957877

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2016

Anticipated Primary Completion Date :

May 1, 2018

Anticipated Study Completion Date :

May 1, 2018

Arms and Interventions

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 Names: 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.

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 Names:

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.

Outcome Measures

Primary Outcome Measures

Prothrombin time [Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis]
Prothrombin time is monitored in both of the LMWH and UFH arms
Activated partial thromboplastin time [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
Anti-Xa level [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
Dialyser urea and creatinine clearances [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
Dialyser thrombus score [At the end of hemodialysis (8th hour)]
Dialyser thrombus score is evaluated in both of the LMWH and UFH arms