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临床试验/NCT06293287
NCT06293287招募中2 期

Enoxaparin for Preventing the Radical Artery Occlusion After the Transradial Access Hepatic Arterial Infusion Chemotherapy: A Multicenter, Randomized Controlled Trial.

Zhongshan Hospital (Xiamen), Fudan University1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2024年1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
状态
招募中
发起方
入组人数
156
试验地点
1
主要终点
RAO rate after 24 hours and 21days

研究概览

简要总结

The present investigation is designed as a single-blind, randomized, controlled, bicentric trial. The objective is to ascertain whether the subcutaneous administration of enoxaparin sodium for prophylactic anticoagulation during transradial hepatic arterial infusion chemotherapy (HAIC) can diminish the incidence of radial artery occlusion (RAO) post-procedure

详细描述

Primary liver cancer ranks sixth globally in incidence and fourth in mortality, with over 800,000 new cases annually . Hepatocellular carcinoma (HCC) accounts for over 80% of primary liver cancers. Due to its insidious onset, most patients present with intermediate to advanced stage disease at diagnosis and are ineligible for curative treatments such as surgical resection or liver transplantation. For unresectable liver cancer, a combination of locoregional therapies (e.g., transarterial chemoembolization, hepatic arterial infusion chemotherapy) and systemic treatments (e.g., targeted therapy, immunotherapy) constitute the standard care.

Hepatic Arterial Infusion Chemotherapy (HAIC) delivers high concentrations of chemotherapy agents directly to the tumor via the hepatic artery, leading to more effective tumor cell kill and suppression. Recent advances in HAIC using the FOLFOX regimen (oxaliplatin, fluorouracil) for intermediate and advanced HCC have been made by researchers in China . However, HAIC typically requires long infusion times. Traditional HAIC involves arterial sheath and catheter placement via the femoral artery, necessitating bed rest for 24-48 hours post-operation, reducing patient comfort, and increasing the risk of deep vein thrombosis in the lower limbs due to prolonged immobilization . Recently, the transradial approach for peripheral intervention has gained attention. Transradial HAIC is favored in clinical practice as it does not require postoperative immobilization or carry the risk of causing deep vein thrombosis in the lower limbs.

Radial artery occlusion (RAO) is the most common complication following transradial interventions, often asymptomatic and diagnosed via radial artery ultrasound. The incidence of RAO post-transradial coronary interventions is reported to be between less than 1% to 33% . Preventive measures for RAO typically include: using catheters of the appropriate size (sheath diameter should be less than the radial artery lumen); intraoperative use of unfractionated heparin, short-term postoperative oral anticoagulation; patent hemostasis and shorter compression times . Transradial HAIC is a relatively new practice with limited research. A recent domestic study indicated that the incidence of RAO following transradial FOLFOX-HAIC was as high as 35%, potentially related to prolonged sheath placement and multiple procedures. Retrospective and prospective analyses suggest that the use of low molecular weight heparin during infusion may reduce the incidence of RAO postoperatively . While prophylactic anticoagulation is standard for patients at high risk of venous thromboembolism, it is not typically administered to low-risk patients. Hence, the potential of enoxaparin sodium for prophylactic anticoagulation during transradial HAIC to reduce RAO incidence warrants further investigation.

RAO can preclude the possibility of future transradial interventions, impacting the patient's options for intervention access and treatment strategy. Thus, preventing RAO following transradial HAIC has significant clinical importance. This study aims to explore the efficacy of prophylactic enoxaparin sodium in preventing postoperative RAO through a randomized controlled trial.

Case Number and Grouping Method:

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
Single (Participant)

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signed informed consent; Age: 18-69 years;
  • Pathologically diagnosed with hepatocellular carcinoma or clinically in accordance with the American Association for the Study of Liver Diseases (AASLD) diagnostic criteria for hepatocellular carcinoma;
  • Clinical stage: BCLC stage B or C, liver function Child-Pugh class A or B$ (≤7 points)$, ECOG $score <2$; suitable for HAIC treatment;
  • Adequate hematological and organ function, i.e., based on laboratory results obtained within 7 days before treatment, such as complete blood count, liver and kidney function, coagulation function, myocardial enzymes, etc., to assess whether the patient is suitable for HAIC treatment;
  • Low-risk patients for VTE (Venous Thromboembolism) according to the Padua scoring system (≤3 points).

排除标准

  • Concomitant primary tumors of other organs or histologically diagnosed tumors inconsistent with hepatocellular carcinoma;
  • Serious diseases of the heart, lungs, kidneys, or other organs;
  • Patients who have received trans-radial interventional surgery within the past 3 months;
  • Patients with thrombocytopenia $and/or $leukopenia due to cirrhosis-related coagulation disorders or splenic hyperfunction are excluded;
  • Preoperative radial artery ultrasound suggests vascular anatomical abnormalities, malformations, etc., unsuitable for trans-radial interventional treatment;
  • Patients with thrombotic diseases who are undergoing anticoagulation therapy;
  • Any unstable conditions or situations that may jeopardize the patient's safety or their compliance with the study;
  • Pregnant and lactating women.

研究组 & 干预措施

placebo

Placebo Comparator

The control group will receive an injection of a placebo (0.9% saline solution) of equal volume once daily.

干预措施: Placebo (Drug)

enoxaparin sodium

Active Comparator

Subjects in the experimental group will be administered subcutaneous enoxaparin sodium injections at a dose of 4000 Axa IU once daily.

干预措施: Subcutaneous enoxaparin sodium (Drug)

结局指标

主要结局

RAO rate after 24 hours and 21days

时间窗: Data will be analyzed immediately after the last participant completes the 21-day post-treatment radial artery Doppler ultrasound assessment.

Radial artery Doppler ultrasounds will be performed 24 hours later and again after 21 days to assess for the occurrence of RAO.

次要结局

未报告次要终点

研究者

发起方
Zhongshan Hospital (Xiamen), Fudan University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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