Advertisement

Topics

Chronic Hemodialysis Without Systemic Heparinization : a Randomized Study

2014-08-27 03:38:34 | BioPortfolio

Summary

Conventional hemodialysis requires transient systemic anticoagulation to prevent blot clotting after contact with the extracorporeal circuit. However, low molecular weight heparin (LMWH) or unfractioned heparin are contra-indicated in dialysis patients at risk for hemorrhagic complications. In this setting, several procedures theoretically allow dialysis without systemic heparinization, but randomized studies to compare them are lacking. The gold standard is the use of iterative rises of the extra corporeal circuit with isotonic saline (" rises "). Two emerging procedures are increasingly used : continuous pre-dilution of the arterial line (" pre-dilution ") and the use of a specific dialysis membrane (NEPHRAL 400 ST) coated with heparin immediately before use (" heparin adsorption ").

Description

Conventional hemodialysis requires transient systemic anticoagulation to prevent blot clotting after contact with the extracorporeal circuit. However, low molecular weight heparin (LMWH) or unfractioned heparin are contra-indicated in dialysis patients at risk for hemorrhagic complications. In this setting, several procedures theoretically allow dialysis without systemic heparinization, but randomized studies to compare them are lacking. The gold standard is the use of iterative rises of the extra corporeal circuit with isotonic saline (" rises "). Two emerging procedures are increasingly used : continuous pre-dilution of the arterial line (" pre-dilution ") and the use of a specific dialysis membrane (NEPHRAL 400 ST) coated with heparin immediately before use (" heparin adsorption ").

We propose a monocentric prospective randomized open study to compare " rises ", " pre-dilution " and " heparin adsorption " in chronic hemodialysis patients with contra-indication to the use of LMWH. Main criteria will be extra-corporeal circuit clotting, with dialysis efficiency and tolerance as secondary criteria. Comparison will be made on grounds of " n-of-1 " trial, i.e. series of randomized cross-over tests in individuals. We have planned to include 75 patients in this study, with 1050 LMWH-free dialysis sessions.

We hope to demonstrate chat by comparison wit rises, pre-dilution and heparin absorption techniques reduce the rate of extra-corporeal circuit by 30 and 50% respectively. We also hope to show that heparin adsorption (i) better preserves membrane integrity throughout the dialysis session, resulting in enhanced dialysis efficiency ; (ii) avoids extra fluid infusion and ultrafiltration, resulting in better dry weigh achievement and better clinical tolerance.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Contra-Indication to the Use of Low Molecular Weight Heparin

Intervention

Dialysis without systemic heparinization

Location

Chu de Necker
Paris
France
75015

Status

Completed

Source

Assistance Publique - Hôpitaux de Paris

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:38:34-0400

Clinical Trials [1970 Associated Clinical Trials listed on BioPortfolio]

Citrate Anticoagulation vs. Heparin-Coated Dialyzers

Hemodialysis causes contact activation of the coagulation pathway (1). For this reason, unfractionated or low molecular weight heparins are administered in daily practice to prevent thromb...

Gemcitabine - Oxaliplatin for Advanced Refractory Thyroid Cancer Patients: a Phase II Study

Radioiodine refractory differentiated thyroid cancer is a rare tumor and therapeutic options are limited in this setting. Molecular targeted therapies have recently been developed for prog...

Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures

A current trend in dialysis membrane engineering is to maximize the permeability for larger low-molecular weight proteins while retaining albumin. Protein-leaking dialysis membranes do not...

The Use of Low Molecular Weight Heparin in Hemodiafiltration

Low molecular weight heparin (LMWH) is injected in the dialysis circuit at the start of the session. In the present study we compare 3 different methods of injection of LMWH: parameters of...

The Application of Ticagrelor Combined With Low Molecular Weight Heparin During PCI

The purpose of this study is to determine ticagrelor combining with low molecular weight heparin is effective and safe during PCI or not.

PubMed Articles [15017 Associated PubMed Articles listed on BioPortfolio]

A modified method of high molecular weight adsorbable organic chlorine measurement in saline water: Dialysis pretreatment.

Adsorbable organic halogen is a mean to quantify total organic halogen, which is an important toxicity indicator in disinfection byproduct studies. However, quantification of low concentrations of ads...

When the color of peritoneal dialysis effluent can be used as a diagnostic tool.

Peritoneal dialysis (PD) effluent is normally transparent. A change in its appearance may be the first indication of an intra- or extraperitoneal abnormality which may or may not be related to the per...

Influence of dialysis membrane composition on plasma bisphenol A levels during online hemodiafiltration.

Bisphenol A (BPA) is an ubiquitous environmental toxin that is also found in dialyzers. Online hemodiafiltration (OL-HDF) more efficiently clears high molecular weight molecules, and this may improve ...

Translational Research of Peritoneal Dialysis Solution with Dissolved Molecular Hydrogen.

Improved biocompatibility of peritoneal dialysis solution (PDS) is crucial for peritoneal membrane preservation, thereby ensuring long-term peritoneal dialysis (PD) and preventing encapsulating perito...

Systemic haemodynamics in haemodialysis: intradialytic changes and prognostic significance.

Although haemodialysis (HD) leads to alterations of systemic haemodynamics that can be monitored using dilution methods, there is a lack of data on the diagnostic and prognostic significance of haemod...

Medical and Biotech [MESH] Definitions

A process of selective diffusion through a membrane. It is usually used to separate low-molecular-weight solutes which diffuse through the membrane from the colloidal and high-molecular-weight solutes which do not. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)

Therapy for the insufficient cleansing of the BLOOD by the kidneys based on dialysis and including hemodialysis, PERITONEAL DIALYSIS, and HEMODIAFILTRATION.

Heparin fractions with a molecular weight usually between 4000 and 6000 kD. These low-molecular-weight fractions are effective antithrombotic agents. Their administration reduces the risk of hemorrhage, they have a longer half-life, and their platelet interactions are reduced in comparison to unfractionated heparin. They also provide an effective prophylaxis against postoperative major pulmonary embolism.

A protein, molecular weight 50 kD, located in various normal tissues. Upon cleavage by KALLIKREINS, it forms KALLIDIN. Kallidin, in turn, is converted into BRADYKININ. (From Stedman, 25th ed)

Portable peritoneal dialysis using the continuous (24 hours a day, 7 days a week) presence of peritoneal dialysis solution in the peritoneal cavity except for periods of drainage and instillation of fresh solution.

More From BioPortfolio on "Chronic Hemodialysis Without Systemic Heparinization : a Randomized Study"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nephrology - kidney function
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...

Dialysis
In medicine, dialysis is a process for removing waste and excess water from the blood, and is primarily used to provide an artificial replacement for lost kidney function in people with renal failure. Dialysis may be used for those with an acute disturba...


Searches Linking to this Trial