Effectiveness and Safety of Heparinization for Radial Artery Occlusion After Transradial Cerebral Angiography in Patients With Acute Ischemic Stroke - A Multicenter, Prospective, Double-blind, Randomized Trail
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- 24 hours radial artery occlusion rate after operation
研究概览
简要总结
Cerebral angiography is a critical diagnostic tool in neurology, serving as the "gold standard" for evaluating cerebrovascular stenosis, hemodynamics, aneurysms, and arteriovenous malformations. Compared to the traditional transfemoral approach, transradial cerebral angiography (TRA) offers advantages such as preserved patient privacy, immediate post-procedure mobility, shorter hospitalization, and fewer access-site complications. Consequently, TRA has gained increasing acceptance among patients and clinicians as the preferred vascular access . However, radial artery occlusion (RAO) remains a common complication post-TRA, with reported incidence rates varying widely (1%-33%). RAO is particularly concerning as the radial artery serves as a key access for both cardiac and neurovascular interventions; its occlusion limits future procedural options.Evidence from interventional cardiology suggests that intra-arterial heparin administration significantly reduces RAO risk.However, patients undergoing transradial cerebral angiography are predominantly those with cerebrovascular diseases, including acute ischemic stroke (AIS)-a population at potential risk for hemorrhagic transformation.Although the 2022 Chinese Expert Consensus on Neurointerventional Diagnosis and Treatment via Transradial Access recommends intra-sheath heparin injection to prevent RAO, this recommendation is largely extrapolated from coronary intervention data. While several studies indicate that low-dose heparin is safe in moderate-to-severe AIS patients without increasing intracranial hemorrhage risk , high-level evidence specific to neurointerventional procedures-particularly in AIS patients-remains lacking.This multicenter, double-blind, randomized controlled trial (RCT) aims to: Evaluate the efficacy of intra-arterial heparin in preventing RAO following TRA cerebral angiography.Assess the safety of heparin in AIS patients, with a focus on hemorrhagic complications. By addressing these questions, the study will provide evidence-based guidance to optimize TRA outcomes, balancing RAO prevention with bleeding risk in neurovascular interventions. Its findings hold significant clinical value for improving the safety and efficacy of transradial cerebral angiography.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Acute ischemic stroke onset within 7 days (inclusive)
- •Patients undergoing cerebral angiography via transradial approach
- •Participant or legal representative capable of providing informed consent
排除标准
- •Current anticoagulation therapy prior to procedure
- •Positive modified Allen's test result
- •History of coronary artery bypass grafting(CABG) with missing right radial artery graft
- •Severe forearm deformities (skin/musculoskeletal) or failed radial artery sheath placement
- •Suspected/confirmed pregnancy or lactation
- •Acute ischemic stroke with hemorrhagic transformation
- •Active systemic bleeding
- •Renal insufficiency (eGFR <30 mL/min or serum creatinine >200 μmol/L)
- •Investigator-determined ineligibility for trial participation
研究组 & 干预措施
Heparin Group
Inject 2,500 units (2mL) of unfractionated heparin intra-arterially via sheath prior to angiography
干预措施: Heparin - Therapeutic dosage (Drug)
Saline (0.9% NaCl)
Inject 2ml saline intra-arterially via sheath prior to angiography
干预措施: Saline (0.9% NaCl) (Drug)
结局指标
主要结局
24 hours radial artery occlusion rate after operation
时间窗: 24 hours±12hours
Radial artery occlusion rate was assessed by ultrasonography 24 hours±12hours after the procedure.
次要结局
未报告次要终点
研究者
Xiang Luo
Professor
Tongji Hospital
