Endstage Renal Disease Clinical Trial
Official title:
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hong Kong | Alice Ho Miu Ling Nethersole Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Alice Ho Miu Ling Nethersole Hospital |
Hong Kong,
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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