Endstage Renal DiseasePhase 4NCT02957877
LMWH Infusion as Anticoagulation for Home HD
A Phase 4 study testing Nadroparin and Unfractionated heparin in people with Endstage Renal Disease, run by Alice Ho Miu Ling Nethersole Hospital at 1 site in Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endstage Renal Disease
- What is being tested?
- Nadroparin and Unfractionated heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteHong Kong
- Study dates
- Mar 2016to May 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prevalent NHHD patients who have received >1 year dialysis with unfractionated heparin as anticoagulant
- Age >= 18
- Informed consent available
Who cannot join
- History of intolerance to LMWHs during HD
- Receiving warfarin or other oral anticoagulant
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Alice Ho Miu Ling Nethersole Hospital
Hong Kong
Steve Siu-Man Wong, MBChB, FRCPC, (852) 26892000, stevesmwong@gmail.com
About this study
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.
Read the 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.
- Conditions
- Endstage Renal Disease
- Being tested
- Nadroparin, Unfractionated heparin
- Keywords
- Anticoagulation, Anti-Xa activity, Low-molecular weight heparin, Unfractionated heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NadroparinDrug
Also called Fraxiparine
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Unfractionated heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prothrombin time
Prothrombin time is monitored in both of the LMWH and UFH arms
Measured: 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
Measured: Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis
Anti-Xa level
Anti-Xa level is only monitored in the LMWH arm
Measured: 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
Measured: 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
Measured: At the end of hemodialysis (8th hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endstage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alice Ho Miu Ling Nethersole Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Siu-Man Wong, Alice Ho Miu Ling Nethersole Hospital
- Investigators
- Steve Siu-Man Wong, MBChB, FRCPC, Principal investigator, Alice Ho Miu Ling Nethersole Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957877
- Sponsor's protocol ID
- 2015.415
- Status last verified
- Nov 2016
- First submitted
- 2 Nov 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 38189593
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-molecular Heparin Infusion as Anticoagulation for Nocturnal Home Hemodialysis
- ClinicalTrials.gov ID
- NCT02957877
- Acronym / sponsor ID
- 2015.415
- Conditions
- Endstage Renal Disease
- Keywords
- Anticoagulation, Anti-Xa activity, Low-molecular weight heparin, Unfractionated heparin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Alice Ho Miu Ling Nethersole HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMWH arm | Experimental | Drug: Nadroparin8-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 |
| UFH arm | Active comparator | Drug: Unfractionated heparin8-hour hemodialysis is performed on alternate day for a week at the dialysis unit (i.e. 3 sessions) by using unfractionated heparin as anticoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prevalent NHHD patients who have received >1 year dialysis with unfractionated heparin as anticoagulant
- Age >= 18
- Informed consent available
Key exclusion criteria (3 listed)
- History of intolerance to LMWHs during HD
- Receiving warfarin or other oral anticoagulant
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NadroparinAlso: FraxiparineA 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. | Drug | LMWH arm |
| Unfractionated heparinThe 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. | Drug | UFH arm |
Primary outcome
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Derived from this study: PubMed 38189593Natale 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.
- Individual participant dataSharing planned: No
Related trials for Endstage Renal Disease
Recruiting
Effect of Apiban Therapy on AVF Maturation in ESRD Patients
Endstage Renal Disease, Direct Oral Anticoagulants (DOACs)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Siu-Man Wong, MBChB, FRCPC principal investigator
Alice Ho Miu Ling Nethersole Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nadroparin and Unfractionated heparin in people with Endstage Renal Disease, run by Alice Ho Miu Ling Nethersole Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steve Siu-Man Wong, MBChB, FRCPC ((852) 26892000, stevesmwong@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prothrombin time (time frame: Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02957877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.