Abstract
BackgroundAnticoagulation for chronic dialysis patients with contraindications to heparin administration is challenging. Current guidelines state that in patients with increased bleeding risks, strategies that can induce systemic anticoagulation should be avoided. Heparin-free dialysis using intermittent saline flushes is widely adopted as the method of choice for patients at risk of bleeding, although on-line blood predilution may also be used. A new dialyzer, Evodial (Gambro, Lund, Sweden), is grafted with unfractionated heparin during the manufacturing process and may allow safe and efficient heparin-free hemodialysis sessions. In the present trial, Evodial was compared to standard care with either saline flushes or blood predilution.MethodsThe HepZero study is the first international (seven countries), multicenter (10 centers), randomized, controlled, open-label, non-inferiority (and if applicable subsequently, superiority) trial with two parallel groups, comprising 252 end-stage renal disease patients treated by maintenance hemodialysis for at least 3 months and requiring heparin-free dialysis treatments. Patients will be treated during a maximum of three heparin-free dialysis treatments with either saline flushes or blood predilution (control group), or Evodial. The first heparin-free dialysis treatment will be considered successful when there is: no complete occlusion of air traps or dialyzer rendering dialysis impossible; no additional saline flushes to prevent clotting; no change of dialyzer or blood lines because of clotting; and no premature termination (early rinse-back) because of clotting.The primary objectives of the study are to determine the effectiveness of the Evodial dialyzer, compared with standard care in terms of successful treatments during the first heparin-free dialysis. If the non-inferiority of Evodial is demonstrated then the superiority of Evodial over standard care will be tested. The HepZero study results may have major clinical implications for patient care.Trial registrationClinicalTrials.gov NCT01318486
Highlights
Anticoagulation for chronic dialysis patients with contraindications to heparin administration is challenging
Heparin-free dialysis using intermittent saline flushes is widely adopted as the method of choice for patients at risk of bleeding [1,2] and is currently recommended by the European Best Practice Guidelines in hemodialysis (2002) [3], the level of evidence is somewhat weak since no randomized controlled studies evaluating this method have been reported to date [4,5,6,7,8,9,10,11]
Clotting phenomena necessitating premature termination of the dialysis session were encountered in 39%, 13% and 0% using AN69 ST, regional citrate anticoagulation (RCA)-Ca3.0 and RCA-Ca0, respectively (P
Summary
Anticoagulation for chronic dialysis patients with contraindications to heparin administration is challenging. Heparin-free dialysis using intermittent saline flushes is widely adopted as the method of choice for patients at risk of bleeding [1,2] and is currently recommended by the European Best Practice Guidelines in hemodialysis (2002) [3], the level of evidence is somewhat weak since no randomized controlled studies evaluating this method have been reported to date [4,5,6,7,8,9,10,11]. Saline infusion is far from optimal for several reasons, including an increased volume load that would need to be removed with dialysis and an added logistic burden on dialysis nurses, owing to the need for close one-to-one nursing in cases of intermittent boluses [1] This technique is still associated with clotting risks (15% to 35%, depending on the literature) which, in addition to blood loss, may reduce the efficiency of a dialysis session that has to be stopped frequently or prematurely. These methods lower the risk of bleeding compared to the standard method, there is still a notable risk of bleeding (5% to 50%) [12]
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