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| Name | Class |
|---|---|
| University Grenoble Alps | OTHER |
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Peripheral arterial disease (PAD) is common in chronic hemodialysis patients (HDC) with a prevalence of 30% according to the DOPPS study.
The combination of PAD and chronic kidney disease (CKD) stage 5 is a risk factor for major amputation (24.5%) with a mortality rate of 55% at 2 years.
Ischemia occurring during PAD is the result of impaired microcirculation, with insufficient blood flow to maintain tissue perfusion and viability.
It is responsible for painful skin wounds whose healing is poor, with a significant risk of infection.
In patients with chronic renal failure, it is linked to both:
Rheopheresis is an apheresis technique that allows the depletion of high molecular weight serum proteins.
This would reduce blood viscosity and red blood cell (RBC) aggregation, thereby improving microvascular perfusion, with the aim of reducing pain, improving healing and limiting the risk of amputation.
Several studies have investigated the efficacy of rheopheresis in PAD in HDC, but the level of evidence remains low.
The main objective of our study is to evaluate the impact of rheopheresis on blood (main objective) and plasma viscosity, skin microcirculation and blood coagulation (Fibrinography, Thrombin Generation).
No study has evaluated the direct effect of rheopheresis on these different parameters.
However, a better understanding of these mechanisms would make it possible both to optimize the effectiveness of the technique, to limit its potential side effects and the cost of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the rheopheresis group | Active Comparator | Rheopheresis is performed using an automated monitor in a double-filtration cascade. Plasma purify from of high molecular weight proteins through a secondary filter is then returned to the patient. This technique is performed in tandem with a hemodialysis monitor. |
|
| the shamapheresis group | Placebo Comparator | Shamapheresis is performed with the same automated monitor (Plasauto, HemaT company). Extracted plasma is not treated through the secondary filter (Rheofilter) and return to the patient. This technique is performed in tandem with a hemodialysis monitor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological analysis | Biological | Rheopheresis using plasma separation and plasma filtration, coupled to hemodialysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood viscosity measured by rotational rheometer | To assess the effect of rheopheresis on blood viscosity of chronic hemodialysis patients with PAD | Immediately before 1ST and immediately after 12th procedure , outcome measurement will be reported at the end of the study (approximately 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood viscosity measured by rotational rheometer | Evaluate the effect of rheopheresis on blood viscosity measured by rotational rheometer before the 12th treatment session | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of rheopheresis on plasma viscosity measured by falling ball viscometer | Plasma viscosity measured by falling ball viscometer in pre vs post session 1 and in pre session 12 vs baseline. | Immediately before day 0 and 12-th procedure and immediately after 1st procedure |
| Evaluate the effect of rheopheresis on skin microvascular function (1st and 12th sessions pre and post session) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HAMZA MD NACIRI BENNANI | Contact | 33476765460 | HNaciribennani@chu-grenoble.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grenoble University Hospital | Grenoble | 38043 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23791036 | Background | Roustit M, Cracowski JL. Assessment of endothelial and neurovascular function in human skin microcirculation. Trends Pharmacol Sci. 2013 Jul;34(7):373-84. doi: 10.1016/j.tips.2013.05.007. Epub 2013 Jun 21. | |
| 29598891 | Result | Meyer A, Fiessler C, Stavroulakis K, Torsello G, Bisdas T, Lang W; CRITISCH collaborators. Outcomes of dialysis patients with critical limb ischemia after revascularization compared with patients with normal renal function. J Vasc Surg. 2018 Sep;68(3):822-829.e1. doi: 10.1016/j.jvs.2017.12.048. Epub 2018 Mar 26. |
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| ID | Term |
|---|---|
| D057919 | Biological Oxygen Demand Analysis |
| ID | Term |
|---|---|
| D004784 | Environmental Monitoring |
| D004781 | Environmental Exposure |
| D004787 | Environmental Pollution |
| D011634 | Public Health |
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Rheopheresis procedure/Shamapheresis procedure
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The efficacy will be assessed by a vascular surgeon blinded to the study group during consultation
Post-occlusive and thermal hyperaemia of cutaneous blood flow measured by speckle contrast imaging, compared between the rheopheresis and shamapheresis groups (1st and 12th sessions pre and post session) |
| Immediately before day0 and 1 years |
| Evaluate the effect of rheopheresis on coagulation | Study of the lifespan of the blood clot (difference between formation time and clot lysis time) using a multi-well plate spectrophotometer (Fibrinography); | Immediately before day 0 and 12-th procedure and immediately after 1st procedure |
| 27390224 | Result | Lowry D, Saeed M, Narendran P, Tiwari A. The Difference Between the Healing and the Nonhealing Diabetic Foot Ulcer: A Review of the Role of the Microcirculation. J Diabetes Sci Technol. 2017 Sep;11(5):914-923. doi: 10.1177/1932296816658054. Epub 2016 Jul 10. |
| 22175277 | Result | Weiss N. A critical review on the use of lipid apheresis and rheopheresis for treatment of peripheral arterial disease and the diabetic foot syndrome. Semin Dial. 2012 Mar-Apr;25(2):220-7. doi: 10.1111/j.1525-139X.2011.01036.x. Epub 2011 Dec 16. |
| 17992654 | Result | Ferrannini M, Vischini G, Staffolani E, Scaccia F, Miani N, Parravano MC, Louis MM, Splendiani G, Di Daniele N. Rheopheresis in vascular diseases. Int J Artif Organs. 2007 Oct;30(10):923-9. doi: 10.1177/039139880703001010. |
| 12887730 | Result | Klingel R, Mumme C, Fassbender T, Himmelsbach F, Altes U, Lotz J, Pohlmann T, Beyer J, Kustner E. Rheopheresis in patients with ischemic diabetic foot syndrome: results of an open label prospective pilot trial. Ther Apher Dial. 2003 Aug;7(4):444-55. doi: 10.1046/j.1526-0968.2003.00082.x. |
| 18937718 | Result | Kirschkamp T, Schmid-Schonbein H, Weinberger A, Smeets R. Effects of fibrinogen and alpha2-macroglobulin and their apheretic elimination on general blood rheology and rheological characteristics of red blood cell aggregates. Ther Apher Dial. 2008 Oct;12(5):360-7. doi: 10.1111/j.1744-9987.2008.00610.x. |
| 11761081 | Result | Briers JD. Laser Doppler, speckle and related techniques for blood perfusion mapping and imaging. Physiol Meas. 2001 Nov;22(4):R35-66. doi: 10.1088/0967-3334/22/4/201. |
| 20542492 | Result | Roustit M, Millet C, Blaise S, Dufournet B, Cracowski JL. Excellent reproducibility of laser speckle contrast imaging to assess skin microvascular reactivity. Microvasc Res. 2010 Dec;80(3):505-11. doi: 10.1016/j.mvr.2010.05.012. Epub 2010 Jun 9. |
| 16965157 | Result | Choi B, Ramirez-San-Juan JC, Lotfi J, Stuart Nelson J. Linear response range characterization and in vivo application of laser speckle imaging of blood flow dynamics. J Biomed Opt. 2006 Jul-Aug;11(4):041129. doi: 10.1117/1.2341196. |
| 16129229 | Result | Stewart CJ, Frank R, Forrester KR, Tulip J, Lindsay R, Bray RC. A comparison of two laser-based methods for determination of burn scar perfusion: laser Doppler versus laser speckle imaging. Burns. 2005 Sep;31(6):744-52. doi: 10.1016/j.burns.2005.04.004. |
| D004778 |
| Environment and Public Health |
| D015980 | Public Health Practice |