Hemostasis Pad Using Chitosan After Invasive Percutaneous Procedures

November 2, 2016 updated by: Si-Hyuck Kang, Seoul National University Bundang Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

315

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 06511
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to hemostasis
Time Frame: Immediately after invasive procedures
Immediately after invasive procedures

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding
Time Frame: within 24 hours
TIMI major/minor bleeding within 24 hours
within 24 hours
Hematoma
Time Frame: within 24 hours
Hematoma within 24 hours
within 24 hours
Retroperitoneal hematoma
Time Frame: within 24 hours
Retroperitoneal hematoma within 24 hours
within 24 hours
Pseudoaneurysm
Time Frame: within 24 hours
Pseudoaneurysm within 24 hours
within 24 hours
Vessel occlusion
Time Frame: within 24 hours

Vessel occlusion within 24 hours (either 1 or 2)

  1. no palpable pulse
  2. no flow on Doppler
within 24 hours
Dissection
Time Frame: within 24 hours

Dissection of access vessel within 24 hours (either 1 or 2)

  1. observed on angiography
  2. symptomatic compromising distal flow
within 24 hours
Surgical repair
Time Frame: within 24 hours
Surgical repair within 24 hours
within 24 hours
Vasovagal reaction
Time Frame: within 24 hours
Vasovagal reaction (grade 3-4) within 24 hours
within 24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hb at discharge
Time Frame: within 24 hours
hemoglobin (g/dL) within 24 hours
within 24 hours
Hb at 1-month F/U
Time Frame: 1 month after discharge
hemoglobin (g/dL) at 1-month outpatient follow-up
1 month after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ezClot1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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