Hemostasis Pad Using Chitosan After Invasive Percutaneous Procedures

Phase 4

• Conditions: Puncture; Coronary Artery Disease
• Interventions: Device: ezClot (hemostasis pad); Device: BloodSTOP ix pad; Device: Rotary compression device

• Registration Number: NCT02954029
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-07-12
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-02
• Last Update Submitted: 2016-11-02
• Study First Posted: 2016-11-03
• Last Update Posted: 2016-11-03
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 315

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group (transradial cohort)	Rotary compression device	device-assisted compression with ezClot pad
Study group (transfemoral cohort)	ezClot (hemostasis pad)	manual compression with ezClot pad
Control group (transradial cohort)	Rotary compression device	Rotary compression device
Study group (transradial cohort)	ezClot (hemostasis pad)	device-assisted compression with ezClot pad
Control group (transfemoral cohort)	BloodSTOP ix pad	manual compression with BloodSTOP ix pad

Primary Outcome Measures

Name	Time	Method
Time to hemostasis	Immediately after invasive procedures

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of