JPRN-jRCT1052220199招募中1 期
Exploratory research to shorten bed rest time after transfemoral artery angiography using a groin compression device (Rebelt) - Rebelt study
Okada Takuya0 个研究点目标入组 200 人开始时间: 2023年3月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable(—)
- 性别
- All
入选标准
- •1. Patients who perform catheter therapy or angiography via trans-femoral artery approach and fulfill the following;
- •1) A 4 or 5Fr. sheath is used.
- •2) Temporary hemostasis is achieved without abnormality by manual compression at the time of sheath removal.
- •3) Compression is started using a rebelt after temporary hemostasis.
- •2. The patient is at least 18 years of age at the time consent is obtained.
- •3. Written consent for participation in this clinical research has been obtained from the patient.
排除标准
- •1. Patients taking two or more antiplatelet or anticoagulant drugs and unable to discontinue medications or reduce dose to aspirin only prior to the procedure.
- •2. Patients with high bleeding risk (platelet count < 50,000, PT-INR >= 1.5).
- •3. Intraoperative use of heparin and ACT at the time of sheath removal is >180 seconds or not measured.
- •4. There are pain, a surgical wound, hernia, or other abnormality at the planned puncture site.
- •5. Inability to maintain supine rest after procedure.
- •6. Difficulty in communicating.
- •7. Other patients deemed inappropriate as research subjects by the investigators.
研究者
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