Low Dose of Argatroban Saline Flushes Anticoagulation in Hemodialysis Patients With High Risk of Bleeding

Zhang, Yixiong; Ning, Jianping; Li, Yanchao; Dai, Siyuan

doi:10.1177/1076029609334628

Cited by 10 publications

(12 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Moreover, as they had to be carefully examined during the dialysis treatment, they could not be completely covered by a label aimed at preventing any differentiation between the two groups. To minimize potential bias due to such an open-label design, it was decided to have the primary end point of the study evaluated using a standardized visual semiquantitative clotting scale, as used in several researches, [23][24][25][26][27] and independently rated by two observers possibly assisted by a third authorized person in case of disagreement. Remarkably, the concordance between the two raters was almost perfect, which does not preclude a certain degree of subjectivity in the assessment of primary outcome-as the decisions to perform additional saline flushes and to terminate dialysis based on level 2 or 3 clotting was often made by the dialysis nurses.…”

Section: Study Limitationsmentioning

confidence: 99%

“…To evaluate the rate of successful treatments, clotting in the air traps was scored using a visual semiquantitative scale: [23][24][25][26][27] Grade 1: No detectable clotting; Grade 2: Minimal clot formation (presence of fibrinous ring); Grade 3: Clot formation (up to 5 cm) but dialysis still possible; Grade 4: Complete occlusion of air traps or dialyzer rendering dialysis impossible.…”

Section: Study End Pointsmentioning

confidence: 99%

See 1 more Smart Citation

Results of the HepZero study comparing heparin-grafted membrane and standard care show that heparin-grafted dialyzer is safe and easy to use for heparin-free dialysis

Laville

Dorval

Ros

et al. 2014

Kidney International

View full text Add to dashboard Cite

Results of the HepZero study comparing heparin-grafted membrane and standard care show that heparin-grafted dialyzer is safe and easy to use for heparin-free dialysis Gambro-Hospal, Meyzieu, FranceHeparin is used to prevent clotting during hemodialysis, but heparin-free hemodialysis is sometimes needed to decrease the risk of bleeding. The HepZero study is a randomized, multicenter international controlled open-label trial comparing no-heparin hemodialysis strategies designed to assess non-inferiority of a heparin grafted dialyzer (NCT01318486). A total of 251 maintenance hemodialysis patients at increased risk of hemorrhage were randomly allocated for up to three heparin-free hemodialysis sessions using a heparin-grafted dialyzer or the center standardof-care consisting of regular saline flushes or pre-dilution. The first heparin-free hemodialysis session was considered successful when there was neither complete occlusion of air traps or dialyzer, nor additional saline flushes, changes of dialyzer or bloodlines, or premature termination. The current standard-of-care resulted in high failure rates (50%). The success rate in the heparin-grafted membrane arm was significantly higher than in the control group (68.5% versus 50.4%), which was consistent for both standardof-care modalities. The absolute difference between the heparin-grafted membrane and the controls was 18.2%, with a lower bound of the 90% confidence interval equal to plus 7.9%. The hypothesis of the non-inferiority at the minus 15% level was accepted, although superiority at the plus 15% level was not reached. Thus, use of a heparin-grafted membrane is a safe, helpful, and easy-to-use method for heparin-free hemodialysis in patients at increased risk of hemorrhage.

show abstract

Section: Study Limitationsmentioning

confidence: 99%

Section: Study End Pointsmentioning

confidence: 99%

Results of the HepZero study comparing heparin-grafted membrane and standard care show that heparin-grafted dialyzer is safe and easy to use for heparin-free dialysis

Laville

Dorval

Ros

et al. 2014

Kidney International

View full text Add to dashboard Cite

show abstract

“…The appropriate approach to preventing the progress of hemorrhagic complications in hemorrhagic patients during hemodialysis treatment is the restriction or avoidance of anticoagulants during hemodialysis. Systemic heparin as an alternative to anticoagulation in this patient group may be administered as regional anticoagulation with heparin and protamine, low-dose heparin, regional anticoagulation with citrate and hemodialysis without anticoagulation with intermittent saline flushes (Galbusera et al, 2009;Yixiong et al, 2010) 6. Electrolyte disorders 6.1 Impaired potassium balances Chronic hemodialysis patients are usually predisposed to hyperkalemia at the beginning of dialysis sessions.…”

Section: Bleeding Diathesismentioning

confidence: 99%

Acute Complications of Hemodialysis

Özkan¹,

Ulusoy²

2011

Technical Problems in Patients on Hemodialysis

View full text Add to dashboard Cite

“…recently compared heparin-free saline flushes with low-dose argatroban (a direct thrombin inhibitor) in a total of 80 hemodialysis sessions performed in 52 patients with high risk of bleeding. They observed a three-fold decrease in major clotting with argatroban ( P <0.05), without safety issues [14]. …”

Section: Introductionmentioning

confidence: 99%

Rationale and design of the HepZero study: a prospective, multicenter, international, open, randomized, controlled clinical study with parallel groups comparing heparin-free dialysis with heparin-coated dialysis membrane (Evodial) versus standard care: study protocol for a randomized controlled trial

Rossignol

Dorval

Fay

et al. 2013

Trials

View full text Add to dashboard Cite

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

show abstract

Low Dose of Argatroban Saline Flushes Anticoagulation in Hemodialysis Patients With High Risk of Bleeding

Abstract: Low dose of argatroban saline flushes is a feasible and safe alternative anticoagulation protocol in HD patients with high risk of bleeding.

Cited by 10 publications

References 17 publications

Results of the HepZero study comparing heparin-grafted membrane and standard care show that heparin-grafted dialyzer is safe and easy to use for heparin-free dialysis

Results of the HepZero study comparing heparin-grafted membrane and standard care show that heparin-grafted dialyzer is safe and easy to use for heparin-free dialysis

Acute Complications of Hemodialysis

Contact Info

Product

Resources

About