Hemodialysis without systemic anticoagulation: a prospective randomized trial to evaluate 3 strategies in patients at risk of bleeding.
OBJECTIVE
In this clinical trial, we aimed to compare three means of performing chronic hemodialysis in patients with contra-indication to systemic heparinization.


METHODS
This open-label monocentric randomized « n-of-one » trial, conducted in a single tertiary care center, recruited chronic hemodialysis patients with a contra-indication to systemic heparinization for at least 3 consecutive sessions. All patients underwent hemodialysis with an AN69ST dialyzer, and were administered three alternative dialysis procedures in a random sequence: intermittent saline flushes, constant saline infusion, or pre-dialysis heparin coating of the membrane. The primary outcome was the need to interrupt the dialysis session because of clotting events due to either (i) a complete coagulation of the circuit; (ii) a partial coagulation of the circuit; (iii) a>50% rise over baseline in the venous pressure.


RESULTS
At the end of the inclusion period (May, 2007 to December, 2008), the number of patients to include (n=75) was not reached: only 46 patients were included and underwent randomization. The study was terminated, and statistical analysis took into account 224 hemodialysis sessions performed in 44 patients with analyzable data. Heparin adsorption was associated with a significant reduction of the need to interrupt the dialysis session because of clotting events: odds ratio 0.3 (CI 95% 0.2 to 0.6; p<0.001, versus intermittent saline flushes). Heparin adsorption was also associated with higher odds for performing >3 h dialysis sessions and for having complete blood restitution. There were no significant effects of the dialysis procedure on weight loss, online ionic dialysance, and adverse events.


CONCLUSIONS
Heparin-coated AN69ST dialysis membrane is a safe and effective method to avoid or delay per-dialytic clotting events in patients with contra-indication to systemic anticoagulation. However, results are not generalizable safely to patients with active bleeding, since weak heparinemia, not assessed in this study, may occur.


BACKGROUND
ClinicalTrials.gov NCT00473109.
Université Paris-Descartes, Faculté de Médecine, Assistance Publique-Hôpitaux de Paris, Service de Néphrologie, Hôpital Necker-Enfants Malades, Paris, France.
Bruno
B
Guéry
Université Denis Diderot, Assistance Publique-Hôpitaux de Paris, Hôpital Robert Debré, Unité d'Epidémiologie Clinique et Institut National de la Santé et de la Recherche Médicale CIE 5, Paris, France.
Corinne
C
Alberti
Université Paris-Descartes, Faculté de Médecine, Assistance Publique-Hôpitaux de Paris, Service de Néphrologie, Hôpital Necker-Enfants Malades, Paris, France.
Aude
A
Servais
Université Paris-Descartes, Faculté de Médecine, Assistance Publique-Hôpitaux de Paris, Service de Néphrologie, Hôpital Necker-Enfants Malades, Paris, France.
Elarbi
E
Harrami
Université Paris-Descartes, Faculté de Médecine, Assistance Publique-Hôpitaux de Paris, Service de Néphrologie, Hôpital Necker-Enfants Malades, Paris, France.
Lynda
L
Bererhi
Université Paris-Descartes, Faculté de Médecine, Assistance Publique-Hôpitaux de Paris, Service de Néphrologie, Hôpital Necker-Enfants Malades, Paris, France.
Brigitte
B
Zins
Université Paris-Descartes, Faculté de Médecine, Assistance Publique-Hôpitaux de Paris, Service de Néphrologie, Hôpital Necker-Enfants Malades, Paris, France.
Malik
M
Touam
Université Paris-Descartes, Faculté de Médecine, Assistance Publique-Hôpitaux de Paris, Service de Néphrologie, Hôpital Necker-Enfants Malades, Paris, France; Institut National de la Santé et de la Recherche Médicale U845, Hôpital Necker-Enfants Malades, Paris, France.
Dominique
D
Joly
D000925:Anticoagulants; D000075202:Contraindications; D017583:Hemodiafiltration / Q000379:methods; D006470:Hemorrhage / Q000517:prevention & control*; D006801:Humans; D008567:Membranes, Artificial; D016017:Odds Ratio; D010297:Paris; D006435:Renal Dialysis / Q000379:methods*; D012965:Sodium Chloride / Q000627:therapeutic use*
D000925:Anticoagulants; D008567:Membranes, Artificial; D012965:Sodium Chloride