Bonkain Florence, Van Hulle Freya, Janssens Peter, Catalano Concetta, Allamani Mandelina, Stolear Jean-Claude, Vandervelde Dominique, Libertalis Mark, Treille Serge, Couttenye Marie M, Dhondt Annemie, Van Biesen Wim, Fils Jean François, Tielemans Christian, Wissing Karl M
Nephrology Department, Universitair Ziekenhuis, Brussels - Belgium.
Nephrology Department, CHU Brugmann, Brussels - Belgium.
J Vasc Access. 2017 Sep 11;18(5):436-442. doi: 10.5301/jva.5000737. Epub 2017 Jun 14.
The prophylactic use of recombinant tissue plasminogen activator once weekly reduces the incidence rate of tunneled cuffed catheter (TCC) malfunction and bacteremia as compared to the exclusive use of heparin as locking solution. Restricting the use of prophylactic thrombolytic agents to patients with a history of thrombotic TCC malfunction could be more cost effective. We conduct a multicenter, double-blind, randomized controlled trial and test the hypothesis that weekly use of urokinase lock will reduce the incidence of thrombotic malfunction by 50% in prevalent hemodialysis patients with a history of thrombotic malfunction.
Patients with a history of at least two separate TCC thrombotic dysfunctions treated with urokinase lock during the 6 months preceding inclusion are recruited in eight Belgian dialysis units. Patients are randomized in two groups: the control group receiving Taurolock™-HEP500 (heparin 500 IU/mL, taurolidine, citrate 4%) after each hemodialysis session and the treatment group receiving Taurolock-U 25,000 (urokinase 25,000, taurolidine, citrate 4%) once a week and the standard Taurolock-HEP500 at the end of the two others sessions. The primary outcome is the incidence rate of TCC thrombotic dysfunction defined by the use of urokinase. The secondary outcomes are the incidence rate of TCC removal and systemic thrombolysis. For the study, both patients and healthcare staff are blinded to treatment allocation.
The present trial is the first to investigate the effect of Taurolock-U 25,000 catheter lock once a week as secondary prevention in hemodialysis patients with the highest risk of TCC-related thrombotic dysfunction.
ClinicalTrials.gov Identifier: NCT02036255.
与仅使用肝素作为封管液相比，每周一次预防性使用重组组织型纤溶酶原激活剂可降低带 cuff 的隧道式导管（TCC）故障和菌血症的发生率。将预防性溶栓药物的使用限制于有血栓形成性 TCC 故障病史的患者可能更具成本效益。我们开展了一项多中心、双盲、随机对照试验，并检验以下假设：对于有血栓形成性故障病史的现患血液透析患者，每周使用尿激酶封管可将血栓形成性故障的发生率降低 50%。
在纳入研究前 6 个月内接受过尿激酶封管治疗且有至少两次独立的 TCC 血栓形成性功能障碍病史的患者，在比利时的 8 个透析单位招募。患者被随机分为两组：对照组在每次血液透析后接受 Taurolock™-HEP500（肝素 500 IU/mL、替考拉宁、枸橼酸盐 4%），治疗组每周一次接受 Taurolock-U 25000（尿激酶 25000、替考拉宁、枸橼酸盐 4%），并在另外两次治疗结束时接受标准的 Taurolock-HEP500。主要结局是使用尿激酶定义的 TCC 血栓形成性功能障碍的发生率。次要结局是 TCC 拔除率和全身溶栓率。对于该研究，患者和医护人员均对治疗分配情况不知情。
本试验首次研究了每周一次使用 Taurolock-U 25000 导管封管作为二级预防措施，对 TCC 相关血栓形成性功能障碍风险最高的血液透析患者的影响。
ClinicalTrials.gov 标识符：NCT02036255。
