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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00473109
First received: May 11, 2007
Last updated: May 22, 2009
Last verified: May 2007
  Purpose

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 ").


Condition Intervention Phase
Contra-Indication to the Use of Low Molecular Weight Heparin
Procedure: Dialysis without systemic heparinization
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Chronic Hemodialysis Without Systemic Heparinization : a Randomized Study

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Need for stopping the meeting for coagulation of the circuit of dialysis: -either complete coagulation of the circuit [ Time Frame: during dialises ] [ Designated as safety issue: Yes ]
  • or coagulation partial of the circuit (a clot is noted in the lines or the trap with bubbles [ Time Frame: during dialeses ] [ Designated as safety issue: Yes ]
  • -or increase in the venous pressure (statement) of the circuit of more than 50 that is to say increase in the venous pressure (statement) of the circuit of more than 50 % beyond its initial value [ Time Frame: during the dialeses ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Loss of effectiveness of dialysis? dialysance of urea during the meeting (online measurement carried out by the generator of dialysis) [ Time Frame: during the dialeses ] [ Designated as safety issue: Yes ]
  • Loss of effectiveness of dialysis overloads hydro-sodic persistent (weight of the patient at the end of the meeting: + 500 grams compared to the basic weight) [ Time Frame: during the dialeses ] [ Designated as safety issue: Yes ]
  • Tolerance of the meeting of dialysis clinical side effects (cephalgias, cramps, arterial hypotension [ Time Frame: during the dialeses ] [ Designated as safety issue: Yes ]
  • Tolerance of the meeting of dialysis hemorrhagic accidents to at the time the 48 hours following the meeting of dialysis [ Time Frame: 48 hours following the meeting of dialysis ] [ Designated as safety issue: Yes ]

Enrollment: 75
Study Start Date: May 2007
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dialysis without systemic heparinization
Dialysis without systemic heparinization
Procedure: Dialysis without systemic heparinization
Dialysis without systemic heparinization
Other Name: Dialysis without systemic heparinization

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473109

Locations
France
Chu de Necker
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Dominique JOLY, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christophe AUCAN, Department Clinical Rechearch of Developpement
ClinicalTrials.gov Identifier: NCT00473109     History of Changes
Other Study ID Numbers: P050311, CRC05032
Study First Received: May 11, 2007
Last Updated: May 22, 2009
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hemodialysis
Heparin
Clotting

ClinicalTrials.gov processed this record on July 28, 2014