Safety and Efficacy of Low-dose Heparinization in Cerebral Angiography: a Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- postoperative cerebral infarction
研究概览
简要总结
Purpose: Systemic heparinization is a widely used technique on digital subtraction angiography (DSA). Heparin, however, is associated with a variety of complications, including hemorrhage, thrombocytopenia, and hematomas. This study aimed to investigate the safety and efficacy of micro-dose systemic heparinization or no heparinization on cerebral angiography for cerebrovascular diseases.
Methods: A prospective, single-blind, randomized controlled study on patients who experienced transient ischemic attacks (TIAs) or acute ischemic strokes and underwent DSA is performed. Participants are randomized into three groups: regular-dose systemic heparinization, micro-dose systemic heparinization, and no heparinization. Information on patient demographics, laboratory tests, perioperative complications, and back pain scores is collected. Safety endpoints are defined as cerebral ischemic events and local complications of puncture site. Efficacy endpoints were defined as the recovery of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-65 years;
- •suspected cerebrovascular disease, including vascular lesions of the carotid, middle cerebral, anterior cerebral, vertebral, basilar, and posterior cerebral arteries;
- •Activity of daily living (ADL) score between 85~100;
- •normal coagulation function and no prior anticoagulant therapy before DSA;
- •fully informed consent to participate in the study.
排除标准
- •iodine allergy;
- •hepatic and/or renal insufficiency;
- •severe hypertension with poor blood pressure control;
- •hemorrhagic diseases;
- •hyperlipidemia;
- •poor glycemic control in diabetes;
- •atrial fibrillation;
- •undergoing interventional treatment simultaneously.
研究组 & 干预措施
Regular-dose group
3000~5000 Units of normal heparin was injected via the sheath tube in the systemic heparinization (Regular-dose) group. Half a dose of normal heparin is added after the imaging session has lasted more than half an hour.
干预措施: Heparin (Drug)
Micro-dose group
Micro-dose group is performed with two bags of 500 milliliter(ml) saline with 2500 Units of heparin were used to make a 5000 Units per liter heparin saline, which was used to infuse anticoagulation.
干预措施: Heparin Sodium Injection (Drug)
heparinization group
No heparinization is performed with no additional heparin is administered by a sheath or arterial route in the third group.
干预措施: No heparinization (Other)
结局指标
主要结局
postoperative cerebral infarction
时间窗: Perioperative period
The safety endpoints of the study were postoperative cerebral infarction on imaging, and local complications such as bleeding at the puncture site, subcutaneous hematoma, and pseudoaneurysm diagnosed by computed tomography angiography (CTA). All patients underwent magnetic resonance imaging within 48 hours after cerebral angiography to check for new ischemic infarction. Postoperative ischemia was characterized as the abrupt appearance of novel neurological deficits, including hemiplegia, hemianopia, aphasia, dysphagia, sensory impairment, or confusion, persisting for more than 24 hours, accompanied with the presence of newly detected cerebral infarction using diffusion-weighted magnetic resonance imaging or computed tomography.
次要结局
- the incidence of pain of surgical limb(24 hours after intervention)
- the incidence of postoperative urethral catheterization(24 hours after intervention)
- the incidence of paralysis of surgical limb(24 hours after intervention)
- Numerical Rating Scale (NRS) for back pain(24 hours after intervention)