跳至主要内容
临床试验/NCT03114722
NCT03114722Unknown2 期

Citrate 4% Versus Heparinised Saline in Preventing Peripherally Inserted Central Catheter (PICC) Occlusions

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2017年7月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
130
试验地点
1
主要终点
Rate of catheter occlusion

研究概览

简要总结

This study is a prospective, randomized, non-blinded study. 1 group will be assigned the standard arm with use of heparinised saline (10U/ml) lock in between each catheter use. This is consistent with the standard procedure of PICC care in the investigators' centre. The second group will be assigned the intervention with use of 4% citrate lock (Dirinco Citra-Lock 4%) in between each catheter use.

详细描述

PICC occlusion in patients requiring long-term central line access for chemotherapy is a recurrent issue. Occlusion is usually managed by administration of fibrinolytic agents, and subsequent removal and re-insertion if unsuccessful.

Locally, the current clinical practice is to use heparinised saline at a concentration of 10U/ml as a locking agent in between use of the PICC line to prevent occlusion. Citrate 4% has antithrombotic and antibacterial properties, which makes it potentially superior to heparin as a locking agent. Citrate chelates ionised calcium in blood, inhibiting calcium-dependent clotting pathways. Also, as a chelating agent, it results in inhibition of growth of micro-organisms. Citrate-based anticoagulation is often preferred over heparin because of its safety and rapid systemic clearance. Citrate also is safe for heparin induced thrombocytopenia patients.

The effects of each agent have been compared in renal patients with central lines on haemodialysis. These studies have demonstrated that 4% citrate is at least equivalent (MacRae, 2008) or even superior (Grudzinski, 2007) to heparin 5000U/ml in preventing catheter occlusions, and superior in preventing infection (Weijmer, 2002).

This study is a prospective, randomized, non-blinded study. 1 group will be assigned the standard arm with use of heparinised saline (10U/ml) lock in between each catheter use. This is consistent with the standard procedure of PICC care in the investigators' centre. The second group will be assigned the intervention with use of 4% citrate lock (Dirinco Citra-Lock 4%) in between each catheter use.

Patients will be followed for up to 6 months or until the catheter is removed, or until the study ends. A standardised data tracking form will be used to assess baseline characteristics as well as number of times urokinase was used. Nursing documentation regarding each PICC flushing (standard documentation as per hospital protocol) will be evaluated for number of discrete attempts made to troubleshoot lines without use of urokinase. Positive blood culture results will be recorded for each patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age more than or equal to 21 years.
  • Histologic or cytologic diagnosis of haematological or oncological malignancy
  • Signed informed consent from patient or legal representative
  • Patients on antiplatelet therapy may be recruited to the study

排除标准

  • Pregnancy.
  • Anticoagulation - warfarin or heparin or novel oral anticoagulants
  • Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.

研究组 & 干预措施

heparin 10U/ml

Active Comparator

Heparinised saline (10U/ml) lock in between each catheter use (with standard twice weekly normal saline flushing if catheter not being used)

干预措施: Heparinised saline (10U/ml) (Drug)

citrate 4%

Experimental

4% citrate lock in between each catheter use (with standard twice weekly normal saline flushing if catheter not being used)

干预措施: Citrate 4% (Drug)

结局指标

主要结局

Rate of catheter occlusion

时间窗: From post insertion to 6 months or until the catheter is removed, whichever is earlier.

Compare the rates of catheter occlusion in patients who receive citrate 4% as a locking agent, versus those who receive heparinised saline (10U/ml).

次要结局

  • Catheter associated bacteraemia(From post insertion to 6 months or until the catheter is removed, whichever is earlier.)
  • Line troubleshooting(From post insertion to 6 months or until the catheter is removed, whichever is earlier.)
  • Bleeding complications(From post insertion to 6 months or until the catheter is removed, whichever is earlier.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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