A Randomized Comparison of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis After Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- the absence of major adverse events on discharge
研究概览
简要总结
This study was performed to evaluate the safety and efficacy of a locally designed Assiut Femoral Compression Device (AFCD) versus manual compression (MC). Femoral compression devices have been developed thorough the past decades without being strongly implemented in the catheterization laboratory. Their limited adoption reflects concerns of high cost and conflicting data regarding their safety
详细描述
The intra-arterial sheaths were removed 6 hours after PCI in the MC group according to the standard local protocols. However for AFCD group, the sheaths were removed 2 hours after PCI instead of conventional 6 hours. To standardize compression times, AFCD were applied to patient and complete femoral artery compression were applied for 5 minutes, followed by a gradual release of pressure till distal pulse is palpated. Each patient received a minimum of 13 minutes of compression, with further compression applied only if full hemostasis had not been achieved at that point with maximum of 30 minutes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 85 years of age,
- •Scheduled to undergo an elective PCI via arterial puncture of common femoral artery were eligible for enrollment in the study.
- •Elective PCI was defined as any coronary revascularization in a low-risk patient who presents to the facility for a planned PCI or for a coronary angiogram followed by ad hoc PCI.
排除标准
- •Patients were excluded from the study if the patient has
- •Any procedural complication included:
- •prolonged chest pain,
- •transient coronary artery closure, no-flow or slow-flow phenomenon,
- •hemodynamic instability,
- •persistent electrocardiographic changes,
- •side-branch occlusion of >1.5 mm, or
- •an angiographically suboptimal result,
- •Arterial access other than the right or left femoral artery ,
- •Vascular perforation, thrombosis during procedure ,
- •Patients with high risk of puncture site complications as:
- •Bleeding diathesis,
- •International normalized ratio >1.5,
- •Recent thrombolysis,
- •Low platelet count,
- •Hematoma at the end of the procedure,
- •Previous iliofemoral artery surgery or any peripheral vascular Surgery,
- •Previous femoral artery complication from angiography, and
- •Uncontrolled hypertension at time of procedure (>180/>110).
结局指标
主要结局
the absence of major adverse events on discharge
时间窗: 24 post procedure
major adverse event (MAE) was defined as symptomatic bleeding associated with hemoglobin drop ≥5 g/dL requiring blood transfusion, fatal bleeding that directly results in death, a pseudoaneurysm or arteriovenous fistula, distal arterial embolism, infections requiring administration of IV antibiotics or debridement, and the need for vascular surgery.
Time-To-Ambulation (TTA), measured in hours
时间窗: TTA was measured from the time the introducer sheath was removed (2 hr in AFCD group and 6 hours in MC group after end of PCI) to time of ambulation
Ambulation was defined as patient standing and walking at least 6 meters (20 feet) without re-bleeding or significant oozing requiring manual compression
次要结局
- Procedure success(24 h post procedure)
- Device success:(5 minutes during application)
研究者
Ayman khairy Mohamed
Dr.
Assiut University