Hemostasis Pad Using Chitosan After Invasive Percutaneous Procedures

Study Overview
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Brief Summary
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Arterial access is the key step during the endovascular treatment of cardiovascular diseases. This study was designed to confirm the safety and efficacy of the hemostasis pad using chitosan 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. The hypothesis will be tested among 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 tranradial coronary procedures.

Detailed Description
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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.

Official Title
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Hemostasis Pad Using Chitosan After Invasive Percutaneous Procedures

Conditions
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Coronary Artery Disease, Puncture

Intervention / Treatment
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* Device: ezClot (hemostasis pad)
* Device: BloodSTOP ix pad
* Device: Rotary compression device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group (transradial cohort)<br>device-assisted compression with ezClot pad | Device: ezClot (hemostasis pad)<br>* ezClot pad uses chitosan, a deacetylated complex carbohydrate derived from the naturally occurring substance chitin, to accelerate blood clotting.<br>Device: Rotary compression device<br>* Rotary compression device consists of a plastic arch and a rotary screw to deliver local pressure by moving the silicone compression pad.<br>|
| Experimental: Study group (transfemoral cohort)<br>manual compression with ezClot pad | Device: ezClot (hemostasis pad)<br>* ezClot pad uses chitosan, a deacetylated complex carbohydrate derived from the naturally occurring substance chitin, to accelerate blood clotting.<br>|
| Active Comparator: Control group (transradial cohort)<br>Rotary compression device | Device: Rotary compression device<br>* Rotary compression device consists of a plastic arch and a rotary screw to deliver local pressure by moving the silicone compression pad.<br>|
| Active Comparator: Control group (transfemoral cohort)<br>manual compression with BloodSTOP ix pad | Device: BloodSTOP ix pad<br>* BloodSTOP® pad is an etherized and oxidized regenerated cellulose matrix that achieves hemostasis by activating the intrinsic coagulation pathway.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hemostasis |  | Immediately after invasive procedures | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | TIMI major/minor bleeding within 24 hours | within 24 hours | 
| Hematoma | Hematoma within 24 hours | within 24 hours | 
| Retroperitoneal hematoma | Retroperitoneal hematoma within 24 hours | within 24 hours | 
| Pseudoaneurysm | Pseudoaneurysm within 24 hours | within 24 hours | 
| Vessel occlusion | Vessel occlusion within 24 hours (either 1 or 2) no palpable pulse no flow on Doppler | within 24 hours | 
| Dissection | Dissection of access vessel within 24 hours (either 1 or 2) observed on angiography symptomatic compromising distal flow | within 24 hours | 
| Surgical repair | Surgical repair within 24 hours | within 24 hours | 
| Vasovagal reaction | Vasovagal reaction (grade 3-4) within 24 hours | within 24 hours |