Trial reportTrials2013
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.
Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01318486 (HepZero), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
HepZero:Heparin Free Dialysis With Evodial: A Prospective Multicenter, Open, Randomized, Controlled Clinical Study With Parallel Groups
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.
- Anticoagulation for people receiving long-term haemodialysis.The Cochrane database of systematic reviews · 2024Pooled it
- Trial
- Extension of Tablo TrEatmeNt Duration (XTEND) study: successful 24 h prolonged therapy with Tablo in critical patients.BMC nephrology · 2022Article
- Impact of Hydrophilic Modification of Synthetic Dialysis Membranes on Hemocompatibility and Performance.Membranes · 2022Review
- Double Pump Sequential Constant Citrate Anticoagulation in General Hemodialysis.Applied bionics and biomechanics · 2022Article
- Timed Controlled Repeated Rotation of the CAR-170-C NXSTAGE Chronic Cartridge Hemodialysis Filter: A Novel Approach to Enabling Heparin-Free Frequent Daily Home Hemodialysis.Mayo Clinic proceedings. Innovations, quality & outcomes · 2021Article
- A comparison of controlled ventilation with a noninvasive ventilator versus traditional mask ventilation.Journal of clinical monitoring and computing · 2020Article
- Micro-computed tomography for the quantification of blocked fibers in hemodialyzers.Scientific reports · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
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.
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