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NCT Number: NCT00473109

Chronic Hemodialysis Without Systemic Heparinization : a Randomized Study

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 ").

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Key information

Conditions

Contra-Indication to the Use of Low Molecular Weight Heparin Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chu de Necker

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dialysis without systemic heparinization

Procedure

Dialysis without systemic heparinization

Primary outcomes

  1. Need for stopping the meeting for coagulation of the circuit of dialysis: -either complete coagulation of the circuit

    Time frame: during dialises

  2. or coagulation partial of the circuit (a clot is noted in the lines or the trap with bubbles

    Time frame: during dialeses

  3. -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

Secondary outcomes

  1. 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

  2. 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

  3. Tolerance of the meeting of dialysis clinical side effects (cephalgias, cramps, arterial hypotension

    Time frame: during the dialeses

  4. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: HDSH

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 14, 2007
Registry last updated
May 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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