End-Stage Renal DiseaseHepFreeHDNCT06224140
Heparin-Free Chronic HemoDialysis Assessment
A study testing Heparin Anticoagulation and Regional Anticoagulation Procedure (RAP) in people with End-Stage Renal Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Intermittent hemodialysis is a complex technique which requires careful monitoring of anticoagulation levels to prevent clotting and reduce the risk of bleeding complications. Dialysis patients often exhibit hypercoagulable tendencies due to uremic state, turbulent blood flows in dialysis procedures, and thrombogenic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- Heparin Anticoagulation and Regional Anticoagulation Procedure (RAP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2024to 1 Sep 2026
- Phase
- Interventional
- 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
- Man or woman aged 18 years or more
- Patients with end-stage renal disease (ESRD) under intermittent hemodialysis, for more than 3 months prior to screening and with a dialysis duration prescription of at least 4 hours
- Effective anticoagulation either by UFH or by LMWH of the dialysis session defined by the absence of circuit loss in the last 3 months.
- Dialysis adequacy defined by a mean Kt/V ≥1.2.
- Calcemia within the normal range at inclusion (2.2 to 2.6 mmol/L) (based on the results of the last monthly blood test)
- Subject affiliated to or beneficiary of a social security system.
- Subject having signed written informed consent.
Who cannot join
- Dysfunctional vascular access at the screening
- Unipunction of the AVF
- Patient treated by hemofiltration or hemodiafiltration procedure
- Current anticoagulation treatment
- Patient treated by digitalizing drugs
- Patient treated by thiazide diuretics
Show all 19Show fewer
- Patient with hypercalcemia and/or hypercalciuria
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Active hemorrhage
- High bleeding risk defined by the following situations: recent bleeding of less than 7 days, recent post-operative period of less than 7 days, recent head trauma of less than 7 days, recent ischemic stroke of less than 7 days, uremic pericarditis.
- Body weight < 45 kg and > 140 kg at screening.
- Known allergy to citrate
- Hospitalization at the screening for all other causes apart from dialysis
- Moribund status (defined by the expectation of death in less than three months).
- Liver failure (to prevent citrate liver toxicity) based on the results of the last monthly or quarterly blood test
- Ongoing participation in a concurrent interventional study in dialysis or with anti-coagulation therapy
- Pregnancy (declarative) or breastfeeding and all the other categories of people with special protection according to the French Code de la Santé Publique (CSP): patients under legal supervision, patients hospitalized without consent, patients admitted in social or sanitary structures for care and not research, and patients in emergency situations
- Patients unable to give an informed consent or unwilling to participate in the study.
- Heparin-coated membrane in current dialysis prescription
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital de la Conception
Marseille, Bouches du Rhône, 13885
Thomas Robert, MD, PhD
About this study
Intermittent hemodialysis is a complex technique which requires careful monitoring of anticoagulation levels to prevent clotting and reduce the risk of bleeding complications. Dialysis patients often exhibit hypercoagulable tendencies due to uremic state, turbulent blood flows in dialysis procedures, and thrombogenic exposure to artificial surfaces of dialysis tubing. Patients with ESRD may experience both dialyzer clotting and excessive bleeding, so individualized heparin dosing and periodic adjustments are necessary to ensure adequate anticoagulation during hemodialysis. The ideal anticoagulant should prevent thrombosis while minimizing the risk of intra- and interdialytic bleeding. The use of heparin carries risks such as worsening of osteoporosis and dyslipidemia, allergic reactions like pruritus, and the potential for life-threatening heparin-induced thrombocytopenia (HIT) for which avoidance of heparin is necessary during dialysis.Heparin, in both its unfractionated heparin (UFH) and low molecular weight heparin (LMWH) forms, is the most commonly used anticoagulant, though evidence comparing their efficacy and risk of bleeding remains inconclusive. End-stage renal disease (ESRD) patients, who are already at higher risk of serious bleeding, may benefit from regional anticoagulation (RA) techniques, as they typically receive around 600,000 IU of heparin per year. The investigators performed routinely a simplified regional anticoagulation procedure (RAP) using a constant calcium re-injection rate over the time to avoid hypocalcemia. This procedure eliminates the need for citrate infusion and calcium monitoring, and reduces nurse workload in a chronic dialysis unit. The investigators compared 21 chronic dialysis patients with 198 RA and 195 heparin sessions, where each patient acted as their own control. None of them were on VKA during the RA sessions, 62% were on single anti-platelet therapy and 14% were on dual anti-platelet therapy. The dialysis session success rate was 94% in the RA group and 97% in the heparin group, with no significant differences (p=0.22). The circuit loss rate was 1.5% per RA session and 0.5% per heparin session (p=0.23), and the early blood restitution rate was 3% and 1.5% (p=0.50) in the RA and heparin groups, respectively
Hypothesis: RAP can be as effective as systemic anticoagulation with heparin for intermittent dialysis in chronic hemodialysis patients, with the potential to reduce the rate of hemorrhagic events
- Conditions
- End-Stage Renal Disease
- Being tested
- Heparin Anticoagulation, Regional Anticoagulation Procedure (RAP)
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin AnticoagulationProcedure or surgery
Conventional dialysis with heparin as anticoagulant treatment
Regional Anticoagulation Procedure (RAP)Procedure or surgery
Dialysis without heparin as anticoagulant but based on the use of a calcium-free dialysis bath. Calcium is then restored by reinjection of a 10% calcium chloride solution.
| Study group | Role | What they receive |
|---|---|---|
| Heparin Anticoagulation | Active comparator | Not described Receives: Procedure: Heparin Anticoagulation |
| Regional Anticoagulation Procedure (RAP) | Experimental | Not described Receives: Procedure: Regional Anticoagulation Procedure (RAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the non-inferiority of the regional anticoagulation procedure compared to heparin anticoagulation on the dialysis sessions success three times per week
The primary endpoint will be the rate of dialysis sessions success over 6 months between two therapeutic strategies:
- Regional anticoagulation procedure (RAP)
- Heparin anticoagulation
Measured: 6 months
Secondary outcomes (13)
Compare between the groups clinical Impact at each dialyses session on bypass loss
Rate of bypass loss
Measured: 6 months
Compare between the groups clinical Impact at each dialyses session on early bypass restitution
Rate of early bypass restitution (defined as a restitution 30 minutes or more before the end of the prescribed time)
Measured: 6 months
Compare between the groups clinical Impact at each dialyses session on dialysis duration
Mean difference of dialysis duration over 6 month between the groups
Measured: 6 months
Compare between the groups clinical Impact at each dialyses session on fistula compression time extended more than 10 minutes
Rate of fistula compression time extended more than 10 minutes after a dialysis session
Measured: 6 months
Compare between the groups clinical Impact during the total duration of the study on incidence of hemorrhagic events
Incidence rate of hemorrhagic events
Measured: 6 months
Compare between the groups clinical Impact during the total duration of the study on dialysis adequacy
Time average-dialysis adequacy difference defined by the average kt/v over 6 months
Measured: 6 months
Compare between the groups clinical Impact during the total duration of the study on relative effects on phosphocalcic balance
Mean difference at months +6 and time-average evolution over 6 month for calcium, phosphor, bone-specific alkaline phosphatase and parathyroid hormone concentration between the groups
Measured: 6 months
Compare between the groups clinical Impact during the total duration of the study on incidence of Hyperparthyroidism
Rate of hyperparathyroidism defined par PTH > 9N at month +6
Measured: 6 months
Compare between the groups clinical Impact during the total duration of the study on incidence of non-hemorrhagic heparin-related complications
Rate of non-hemorrhagic heparin-related complications:
- In the heparin group: heparin-induced thrombocytopenia,
- Between the groups: hyperkalemia, hypertriglyceridemia, hypersensitivity reactions, pruritus at months +6
Measured: 6 months
Compare between the groups clinical Impact during the total duration of the study on incidence of cardiovascular-related mortality and major cardiovascular events (MACE)
Incidence rate of MACE at months +6
Measured: 6 months
Compare between the groups clinical Impact during the total duration of the study on global mortality
All-cause mortality rate at month +6
Measured: 6 months
Compare between the groups the tolerance of per-dialytic hypotension
Rate of per-dialytic hypotension over 6 months
Measured: 6 months
Compare between the groups the tolerance of adverse events
Rate of adverse events over 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start6 Jun 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224140
- Sponsor's protocol ID
- RCAPHM21_0424_HEPFREEHD
- Acronym
- HepFreeHD
- Status last verified
- Oct 2024
- First submitted
- 16 Jan 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin-Free Chronic HemoDialysis Assessment
- ClinicalTrials.gov ID
- NCT06224140
- Acronym / sponsor ID
- HepFreeHD / RCAPHM21_0424_HEPFREEHD
- Conditions
- End-Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 25 Jan 2024 (actual)
- 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.
Intermittent hemodialysis is a complex technique which requires careful monitoring of anticoagulation levels to prevent clotting and reduce the risk of bleeding complications. Dialysis patients often exhibit hypercoagulable tendencies due to uremic state, turbulent blood flows in dialysis procedures, and thrombogenic exposure to artificial surfaces of dialysis tubing. Patients with ESRD may experience both dialyzer clotting and excessive bleeding, so individualized heparin dosing and periodic adjustments are necessary to ensure adequate anticoagulation during hemodialysis. The ideal anticoagulant should prevent thrombosis while minimizing the risk of intra- and interdialytic bleeding. The use of heparin carries risks such as worsening of osteoporosis and dyslipidemia, allergic reactions like pruritus, and the potential for life-threatening heparin-induced thrombocytopenia (HIT) for which avoidance of heparin is necessary during dialysis.Heparin, in both its unfractionated heparin (UFH) and low molecular weight heparin (LMWH) forms, is the most commonly used anticoagulant, though evidence comparing their efficacy and risk of bleeding remains inconclusive. End-stage renal disease (ESRD) patients, who are already at higher risk of serious bleeding, may benefit from regional anticoagulation (RA) techniques, as they typically receive around 600,000 IU of heparin per year. The investigators performed routinely a simplified regional anticoagulation procedure (RAP) using a constant calcium re-injection rate over the time to avoid hypocalcemia. This procedure eliminates the need for citrate infusion and calcium monitoring, and reduces nurse workload in a chronic dialysis unit. The investigators compared 21 chronic dialysis patients with 198 RA and 195 heparin sessions, where each patient acted as their own control. None of them were on VKA during the RA sessions, 62% were on single anti-platelet therapy and 14% were on dual anti-platelet therapy. The dialysis session success rate was 94% in the RA group and 97% in the heparin group, with no significant differences (p=0.22). The circuit loss rate was 1.5% per RA session and 0.5% per heparin session (p=0.23), and the early blood restitution rate was 3% and 1.5% (p=0.50) in the RA and heparin groups, respectively
Hypothesis: RAP can be as effective as systemic anticoagulation with heparin for intermittent dialysis in chronic hemodialysis patients, with the potential to reduce the rate of hemorrhagic events
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heparin Anticoagulation | Active comparator | Procedure: Heparin Anticoagulation |
| Regional Anticoagulation Procedure (RAP) | Experimental | Procedure: Regional Anticoagulation Procedure (RAP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Man or woman aged 18 years or more
- Patients with end-stage renal disease (ESRD) under intermittent hemodialysis, for more than 3 months prior to screening and with a dialysis duration prescription of at least 4 hours
- Effective anticoagulation either by UFH or by LMWH of the dialysis session defined by the absence of circuit loss in the last 3 months.
- Dialysis adequacy defined by a mean Kt/V ≥1.2.
- Calcemia within the normal range at inclusion (2.2 to 2.6 mmol/L) (based on the results of the last monthly blood test)
Key exclusion criteria (19 listed)
- Dysfunctional vascular access at the screening
- Unipunction of the AVF
- Patient treated by hemofiltration or hemodiafiltration procedure
- Current anticoagulation treatment
- Patient treated by digitalizing drugs
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 |
|---|---|---|
| Heparin AnticoagulationConventional dialysis with heparin as anticoagulant treatment | Procedure or surgery | Heparin Anticoagulation |
| Regional Anticoagulation Procedure (RAP)Dialysis without heparin as anticoagulant but based on the use of a calcium-free dialysis bath. Calcium is then restored by reinjection of a 10% calcium chloride solution. | Procedure or surgery | Regional Anticoagulation Procedure (RAP) |
Primary outcome
Demonstrate the non-inferiority of the regional anticoagulation procedure compared to heparin anticoagulation on the dialysis sessions success three times per week
Time frame: 6 months
The primary endpoint will be the rate of dialysis sessions success over 6 months between two therapeutic strategies: * Regional anticoagulation procedure (RAP) * Heparin anticoagulation
13 secondary outcomes
Compare between the groups clinical Impact at each dialyses session on bypass loss
Time frame: 6 months
Compare between the groups clinical Impact at each dialyses session on early bypass restitution
Time frame: 6 months
Compare between the groups clinical Impact at each dialyses session on dialysis duration
Time frame: 6 months
Compare between the groups clinical Impact at each dialyses session on fistula compression time extended more than 10 minutes
Time frame: 6 months
Compare between the groups clinical Impact during the total duration of the study on incidence of hemorrhagic events
Time frame: 6 months
Compare between the groups clinical Impact during the total duration of the study on dialysis adequacy
Time frame: 6 months
Compare between the groups clinical Impact during the total duration of the study on relative effects on phosphocalcic balance
Time frame: 6 months
Compare between the groups clinical Impact during the total duration of the study on incidence of Hyperparthyroidism
Time frame: 6 months
Compare between the groups clinical Impact during the total duration of the study on incidence of non-hemorrhagic heparin-related complications
Time frame: 6 months
Compare between the groups clinical Impact during the total duration of the study on incidence of cardiovascular-related mortality and major cardiovascular events (MACE)
Time frame: 6 months
Compare between the groups clinical Impact during the total duration of the study on global mortality
Time frame: 6 months
Compare between the groups the tolerance of per-dialytic hypotension
Time frame: 6 months
Compare between the groups the tolerance of adverse events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin Anticoagulation and Regional Anticoagulation Procedure (RAP) in people with End-Stage Renal Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 7 inclusion and 19 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 26 Oct 2024. 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 France. 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.
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 Thomas Robert (04 91 38 41 17 ext. +33, thomas.robert@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the non-inferiority of the regional anticoagulation procedure compared to heparin anticoagulation on the dialysis sessions success three times per week (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2024.