AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
  • Hôpital de la Conception

    Marseille, Bouches du Rhône, 13885

    Thomas Robert, MD, PhD

    Recruiting

Other trials in France

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

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 groups in NCT06224140
Study groupRoleWhat they receive
Heparin AnticoagulationActive comparatorNot described
Receives: Procedure: Heparin Anticoagulation
Regional Anticoagulation Procedure (RAP)ExperimentalNot described
Receives: Procedure: Regional Anticoagulation Procedure (RAP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. Compare between the groups clinical Impact at each dialyses session on bypass loss

    Rate of bypass loss

    Measured: 6 months

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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:

    1. In the heparin group: heparin-induced thrombocytopenia,
    2. Between the groups: hyperkalemia, hypertriglyceridemia, hypersensitivity reactions, pruritus at months +6

    Measured: 6 months

  10. 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

  11. 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

  12. Compare between the groups the tolerance of per-dialytic hypotension

    Rate of per-dialytic hypotension over 6 months

    Measured: 6 months

  13. 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.

  1. First posted25 Jan 2024
  2. Study start6 Jun 2024
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Sep 2026 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in