A Randomised Controlled Trial to Compare Conventional and Haemostatic Dressings to Achieve Rapid and Effective Haemostasis Following Radial Artery Access
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2,114
- 试验地点
- 2
- 主要终点
- The rate of failure to achieve haemostasis at the planned compression time
研究概览
简要总结
The purpose of this study is to compare different protocols aimed at achieving haemostasis (i.e. stop the bleeding) in patients undergoing heart procedures with access through the wrist. Specifically, a haemostatic dressing that aids clotting at the level of the skin will be used and compared with a normal absorbent dressing. Also, a shorter time of compression required to stop the bleeding at the access site will be evaluated.
详细描述
Radial access for percutaneous cardiac procedures is the preferred method used by most interventional cardiologists. This method has proven to have the least complications and a much quicker patient's recovery time, compared to other access sites (e.g. femoral or brachial). Following sheath removal, a dressing is applied on the skin at the access site. Dressing currently in use include:
- Conventional absorbent - an absorbent sterile adhesive dressing. This is our current, standard care.
- Haemostatic - a sterile mineral-based absorbent dressing that aids clotting. It is not currently used at Liverpool Heart and Chest Hospital (LHCH), but it is a licenced product.
A radial compression device is placed over the dressing, and it applies the appropriate amount of mechanical pressure to guarantee patent haemostasis.
This study will recruit patients who are undergoing a cardiac procedure with intended radial access, as part of their standard care. The aim of this study to look at new techniques to reduce the time to successful and complete haemostasis. This may help to expedite patient discharge (avoiding unplanned overnight stay), to reduce nursing times and to decrease the rate of post-procedural, access site-related bleeding and ischemic complications.
At the end of the cardiac procedure, participants will be randomised in a 1:1:1 ratio to one of the following 3 arms:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •< 18 years of age
- •Planned bilateral radial access
- •Any haematoma (> 5 cm in its longest dimension) at planned puncture site prior to radial sheath insertion
- •Established diagnosis of any haematologic disorder or genetic defect predisposing to bleeding
- •Patients with International Normalised Ratio (INR) > 2.5 prior to the scheduled angiographic procedure
- •Inability to perform adequate consent: communication issues (e.g. mental capacity); inadequate time for the participant to read and consider trial; unscheduled Urgent or Emergency procedures i.e. PPCI
- •Patients who are scheduled to be transferred to other hospitals ("treat and return") before haemostasis is achieved.
- •Electronic Patient Record technical failure leading to an inability to record participants' care
- •In-Cath Lab Inclusion Criterion:
- •Single radial sheath in situ with planned removal in lab
- •In-Cath Lab Exclusion Criteria:
- •Sheath removal after 17:00 hrs
- •Patient leaving lab with radial sheath in situ
- •Trans-ulnar procedure
- •Distal (snuffbox) trans-radial procedure
- •Any puncture-related haematoma (> 5cm in its longest dimension) prior to radial sheath removal
- •Randomisation system not available
- •Dressings of both types not available
- •A change in patient's clinical condition during procedure deemed by the operator sufficient to exclude from the trial
- •Procedural complication requiring procedure termination
结局指标
主要结局
The rate of failure to achieve haemostasis at the planned compression time
时间窗: Estimated average of 90 minutes
After radial sheath is removed and initial haemostasis is secured by Cath Lab team, new overt bleeding or puncture-related haematoma development, occurring out of the Cath Lab, during planned compression period such that: * an additional compression device or pressure dressing is applied OR * the radial dressing and compression device (either original device or new device) are re-applied de novo OR * planned compression duration period to be restarted OR At the time of planned compression device removal, perceived failure of puncture site haemostasis, manifest as overt bleeding or puncture-related haematoma, that requires re-application of compression (either with the original device, a new device, an additional device, manual compression or a pressure dressing)
次要结局
- Rate of bleeding complications(From randomisation until discharge from hospital, estimated average of 8 hours)
- Incidence of post-procedural radial artery occlusion(From randomisation until discharge from hospital, estimated average of 8 hours)
- Incidence of patients with delayed discharge due to the need for radial access site care(Estimated average 12 hours)
- Time to Haemostasis(From randomisation until discharge from hospital, estimated average of 8 hours)