Chronic Hemodialysis Without Systemic Heparinization : a Randomized Study (HDSH)

A

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed
Phase 3

Conditions

Contra-Indication to the Use of Low Molecular Weight Heparin

Treatments

Procedure: Dialysis without systemic heparinization

Study type

Interventional

Funder types

Other

Identifiers

NCT00473109
P050311
CRC05032

Details and patient eligibility

About

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 ").

Full 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.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Chronic hemodialysis patient
  • Low molecular weight heparin contra indicated for at least 3 consecutive hemodialysis sessions.

Exclusion criteria

  • Acute renal failure
  • Access flow < 250 ml/mn)
  • Per dialytic Blood transfusion or parenteral nutritional support
  • Systolic BP < 80 mm Hg
  • Hemoglobin > 13 g/dl

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 1 patient group

Dialysis without systemic heparinization
Experimental group
Description:
Dialysis without systemic heparinization
Treatment:
Procedure: Dialysis without systemic heparinization

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems