Primary objective:- To determine the effectiveness of Evodial, as compared with standard of care in terms of successful treatments during the first heparin free dialysis treatment. If the non-inferiority of Evodial is demonstrated, the superiority…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Chronic end-stage renal disease
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluation of succes rates during the first heparin free dialysis treatment.
The first heparin free dialysis treatment will be considered successful when
there is :
- No complete occlusion of air traps or dialyzer rendering dialysis impossible
(grade 4 of the scale).
- No additional saline flushes to prevent clotting.
- No change of blood lines/ dialyzer because of clotting.
- No premature stop /early rinse-back due to clotting.
Evaluation of clotting in the air traps will be performed at each hour along
the dialysis session by using a semi quantitative scale described below:
- Grade 1: No detectable clotting
- Grade 2: Minimal clot formation (presence of fibrinous ring)
- Grade 3: Clot formation (up to 5 cm) but dialysis still possible
- Grade 4: Complete occlusion of air traps or dialyzer rendering dialysis
impossible
The evaluation (clotting scoring) will be performed hourly by two independent
observers. In any cases, including a potential dispute between the two
observers, the decision to stop the dialysis session must be made only by
authorized and trained members of the medical team i.e. the principal
investigator or registered co-investigator.
Secondary outcome
Evaluation of success rates during the second and the third consecutive
heparin free dialysis treatment.
As for the first heparin free dialysis treatment, treatments will be considered
successful when there is :
- No complete occlusion of air traps or dialyzer rendering dialysis impossible
(grade 4 of the scale).
- No additional saline flushes to prevent clotting.
- No change of blood lines/ dialyzer because of clotting.
- No premature stop /early rinse-back due to clotting.
The evaluation (clotting scoring) will be performed hourly by two independent
observers as for the first heparin free dialysis treatment described in section
above regarding " Primary study parameters/outcome").
Efficacy assessment:
- The UF achieved and weight loss, urea and creatinine reduction rates and also
ionogram will be documented during all dialysis sessions.
Ease of use:
- To measure ease of use, frequency and remaining volume of saline flushes will
be documented.
Safety:
- The occurrence of AEs/SAEs during the study will be collected.
Background summary
Hemodialysis patients with an increased bleeding risk are usually dialysed with
low-dose anticoagulation or without any anticoagulation, often in combination
with *predilution flow* (NaCl 0.9 % 1-2 l/h). Unfortunately, such HD sessions
are often complicated by clotting of the extracorporeal system resulting in
blood loss and early termination of the dialysis session and, thus, inadequate
volume and solute removal. More subtle clotting in a proportion of dialyser
fibre bundles may further contribute to inefficient hemodialysis.
Gambro Lundia AB, sponsor of the study and manufacturer of medical devices for
hemodialysis, has developed a new hemodialyzer called Evodial. This dialyzer is
composed of a dialysis membrane grafted with heparin (no release of heparin in
the blood). The grafted heparin keeps its anticoagulant properties therefore it
allows a regional anticoagulation limited to the blood circuit and avoid
flushing of the extracorporeal circuit during hemodialysis session to prevent
clotting of dialyzer and blood lines. This dialyzer is a CE marked,
commercialized for 2 years and used in many dialysis centers.
Clinical studies carried out in 2007 and 2009 have shown, among a population of
chronic dialysis patients without hemorrhagic risks that Evodial dialyzer
permitted dialysis session decreasing by about 50% the usual heparin doses. No
unexpected adverse reactions occurred during these studies.
The purpose of the HepZero study is to show, during the first heparin free
dialysis session, that results using Evodial dialyzer without saline rinsing
during the session are not inferior to the usual rinsing technique using saline
flushes with regard to the proportion of dialysis sessions performed until
treatment duration schedule without massive clotting of the extracorporeal
circuit.
Study objective
Primary objective:
- To determine the effectiveness of Evodial, as compared with standard of
care in terms of successful treatments during the first heparin free dialysis
treatment.
If the non-inferiority of Evodial is demonstrated, the superiority of Evodial
over standard of care will be tested.
Secondary objectives:
- To compare the success rate during the 2nd and 3rd consecutive heparin free
treatment with Evodial to standard of care.
- To compare clotting grading in air traps during all treatments with Evodial
versus standard of care.
- To assess the efficacy of heparin free dialysis treatment with Evodial vs.
standard of care.
- To assess the easy of use of heparin free treatment with Evodial.
- To assess the safety of heparin free treatment with Evodial vs. heparin free
treatment with standard therapy.
Study design
Prospective, multicenter, open, controlled, randomized clinical study with two
parallel groups.
Intervention
Two types of therapies will be evaluated in parallel:
- Control Group: Heparin free hemodialysis treatment according to standard of
care.
- Study Group: Heparin free hemodialysis treatment with Evodial (study product).
All enrolled patients in the study will be treated during a maximum of 3
heparin free dialysis treatments
Study burden and risks
Foreseeable risks for the patients included in this clinical study do not
differ from those usually observed during this type of treatment.
No additional risk directly related to the use of the product can be
objectively foreseen.
For all patients, a very close care will be performed:
- follow-up of clotting in the air traps every hour during the dialysis
session, that could be considered as a benefit.
- For the patients randomized to the study product (Evodial dialyzer) it could
be expected that the treatment may be superior to the standard care heparin
free treatment, considering clotting.
Magistratsvägen 16 P,O Box 10101
220 10 LUND
SE
Magistratsvägen 16 P,O Box 10101
220 10 LUND
SE
Listed location countries
Age
Inclusion criteria
1. Patients requiring heparin free dialysis treatments on nephrologists' prescription.
2. Chronic end-stage renal disease (ESRD) patients treated by maintenance hemodialysis for at least 3 months.
3. Patients with a well functioning blood access that can allow a blood flow of at least 250 ml/min.
4. Patients aged 18 years or more.
5. Written consent to participate in the study;Patients that have already been treated with heparin free hemodialysis can be included into the study: first treatment meaning first treatment evaluated when patient is enrolled in the study.
Patients with a central venous catheter locked by heparin can be included in the study but a particular attention has to be paid to the sucking of heparin and the rinsing of catheter before starting the hemodialysis treatment.
Exclusion criteria
1. Patients in ICU (intensive care unit) setting.
2. AKI (acute kidney injury) patients.
3. Patients dialyzed in self care, satellite HD units.
4. Patients treated in single needle mode.
5. Known contraindication for heparin (HIT type II).
6. Patients requiring blood and other labile blood producs (i.e fresh frozen
plasma, platelets, etc).
7. Patients receiving oral anticoagulants (including anti-vitamin K).
8. Patients receiving a combination (e.g. aspirin and clopidogrel) of anti-platelets agents
9. Patients treated with unfractionated or low molecular weight heparin beside
the dialysis treatment to prevent deep vein thrombosis.
10. Pregnant/planning pregnancy and lactating women during the study period.
11. Adults patients protected by law.
12. Patients that are not affiliated to health insurance system.
13. Participation in other interventional studies during the study period.
14. Patients that have already been included in this study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Clin.trial.gov. |
| CCMO | NL36003.042.11 |