Hemostasis Pad Using Chitosan After Invasive Percutaneous Procedures
Ключевые слова
абстрактный
Описание
Arterial access is the key step during the endovascular treatment of cardiovascular diseases. However, failure in hemostasis of the arterial access sites is associated with high risk of complications such as bleeding, pseudoaneurysm, and arteriovenous fistula. Major bleeding events after percutaneous coronary intervention has been shown be associated with poor short-term as well as long-term prognosis. Thus, there have been a variety of approaches to quickly and effectively achieve hemostasis of the puncture site. The traditional method was to apply manual compression followed by simple dressing directly on the puncture site. Despite a long history and economic advantage, this method required prolonged hemostasis time, substantial efforts by trained practitioner, and patients' discomfort.
Use of hemostasis pad that accelerates blood clotting has become an effective alternative. The ezClot pad is a new product that uses chitosan, a deacetylated complex carbohydrate derived from the naturally occurring substance chitin. The positively charged chitosan molecules attract the negatively charged blood cells and platelets, thus promoting clots. The ability to hemostasis of chitosan has been proven with the HemCon® pad (HemCon Medical Technologies, Inc., Portland, OR, USA). This study was designed to confirm the safety and efficacy of the ezClot pad in patients undergoing percutaneous procedures with arterial approach. Two cohorts will be included in this study: transradial and transfemoral cohort. Among the transfemoral cohort, the safety and efficacy of the ezClot pad will be compared with the BloodSTOP® pad (LifeScience PLUS, Palo Alto, CA, USA). The BloodSTOP® pad is an etherized and oxidized regenerated cellulose matrix that achieves hemostasis by activating the intrinsic coagulation pathway.
Transradial approach is increasing used during coronary procedures. The most important benefit of transradial approach compared to transfemoral approach is low risk of major bleeding. Widely used method for hemostasis of radial puncture sites were manual or device-assisted compression. There is yet only a limited data regarding the use of hemostasis pad after transradial approach. The hypothesis will be tested in the transradial cohort that the combined use of a hemostasis pad and a compression device is superior to that of a compression device only in terms of hemostasis in patients who underwent transradial coronary procedures.
Даты
Последняя проверка: | 10/31/2016 |
Первый отправленный: | 07/11/2016 |
Предполагаемая регистрация отправлена: | 11/01/2016 |
Первое сообщение: | 11/02/2016 |
Последнее обновление отправлено: | 11/01/2016 |
Последнее обновление опубликовано: | 11/02/2016 |
Фактическая дата начала исследования: | 03/31/2016 |
Предполагаемая дата завершения начальной школы: | 11/30/2016 |
Предполагаемая дата завершения исследования: | 11/30/2017 |
Состояние или болезнь
Вмешательство / лечение
Device: ezClot (hemostasis pad)
Device: Control group (transfemoral cohort)
Device: Rotary compression device
Фаза
Группы рук
Рука | Вмешательство / лечение |
---|---|
Experimental: Study group (transradial cohort) device-assisted compression with ezClot pad | |
Experimental: Study group (transfemoral cohort) manual compression with ezClot pad | |
Active Comparator: Control group (transradial cohort) Rotary compression device | |
Active Comparator: Control group (transfemoral cohort) manual compression with BloodSTOP ix pad | Device: Control group (transfemoral cohort) BloodSTOP® pad is an etherized and oxidized regenerated cellulose matrix that achieves hemostasis by activating the intrinsic coagulation pathway. |
Критерии приемлемости
Возраст, имеющий право на обучение | 18 Years Чтобы 18 Years |
Полы, имеющие право на обучение | All |
Принимает здоровых добровольцев | да |
Критерии | Inclusion Criteria: - age 18 years or older - patients undergoing invasive procedures via the radial or femoral arteries Exclusion Criteria: - congenital or acquired bleeding tendency - platelet count <50,000/ μL - hypersensitivity to shrimps, lobsters or beetles |
Результат
Основные показатели результатов
1. Time to hemostasis [Immediately after invasive procedures]
Меры вторичного результата
1. Bleeding [within 24 hours]
2. Hematoma [within 24 hours]
3. Retroperitoneal hematoma [within 24 hours]
4. Pseudoaneurysm [within 24 hours]
5. Vessel occlusion [within 24 hours]
6. Dissection [within 24 hours]
7. Surgical repair [within 24 hours]
8. Vasovagal reaction [within 24 hours]
Другие показатели результатов
1. Hb at discharge [within 24 hours]
2. Hb at 1-month F/U [1 month after discharge]