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Ankaferd Blood Stopper for Hemostasis After Transradial Coronary Angiography

Primary Purpose

Radial Artery Injury, Hematoma, Bleed

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

ABS

TR Band

About this trial

This is an interventional prevention trial for Radial Artery Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All consecutive patients undergoing transradial elective diagnostic coronary procedures between November 2016 and November 2017 at the catheterization laboratory of Acibadem University Kocaeli Hospital were considered to be enrolled in the study.

Exclusion Criteria:

The only exclusion criteria were an abnormal Barbeau's test before puncture and failure to provide written informed consent.

Sites / Locations

Acibadem UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

ABS

TR BAND

Arm Description

Ankaferd blood stopper

Conventional sterile gauze

Dedicated hemostatic device

Outcomes

Primary Outcome Measures

Radial artery occlusion assessed by reverse Barbeau's test

Secondary Outcome Measures

Bleeding

any kind of bleeding defined as ml after the removal of hemostatic dressings or devices

Hematoma

hematomas larger then >5cm

Full Information

NCT ID

NCT02982733

First Posted

November 23, 2016

Last Updated

December 2, 2016

Sponsor

Acibadem University

1. Study Identification

Unique Protocol Identification Number

NCT02982733

Brief Title

Ankaferd Blood Stopper for Hemostasis After Transradial Coronary Angiography

Official Title

Ankaferd Blood Stopper as a New Strategy to Avoid Early Complication After Transradial Coronary Angiography: A Randomized, Placebo-Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

November 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Acibadem University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

In 2008 Goker et al, introduced Ankaferd Blood Stopper (ABS) as a new hemostatic drug. Recently, ABS has been shown to produce local hemostasis by implementing topically after major arterial vessel injury. Reducing the compression time during patent hemostasis by facilitating hemostasis may decrease RAO. To test this hypothesis the investigators planned a three arm randomized study to evaluate the safety and efficacy of Ankaferd blood stopper in adjunct to short-time compression, compared to either short-time compression with conventional sterile gauzes or with a TR band after transradial diagnostic procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radial Artery Injury, Hematoma, Bleed

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ABS

Arm Type

Active Comparator

Arm Description

Ankaferd blood stopper

Arm Title

Arm Type

Placebo Comparator

Arm Description

Conventional sterile gauze

Arm Title

TR BAND

Arm Type

Active Comparator

Arm Description

Dedicated hemostatic device

Intervention Type

Other

Intervention Name(s)

ABS

Intervention Description

Ankaferd Blood Stopper

Intervention Type

Device

Intervention Name(s)

TR Band

Intervention Description

Transradial band

Intervention Type

Other

Intervention Name(s)

Intervention Description

Sterile Gauze

Primary Outcome Measure Information:

Title

Radial artery occlusion assessed by reverse Barbeau's test

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Bleeding

Description

any kind of bleeding defined as ml after the removal of hemostatic dressings or devices

Time Frame

2 hours

Title

Hematoma

Description

hematomas larger then >5cm

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All consecutive patients undergoing transradial elective diagnostic coronary procedures between November 2016 and November 2017 at the catheterization laboratory of Acibadem University Kocaeli Hospital were considered to be enrolled in the study. Exclusion Criteria: The only exclusion criteria were an abnormal Barbeau's test before puncture and failure to provide written informed consent.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sevket Gorgulu, Prof

Phone

02623174121

sevket5@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sevket Gorgulu, Prof

Organizational Affiliation

Acibadem University

Official's Role

Study Chair

Facility Information:

Facility Name

Acibadem University

City

İstanbul

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sevket Gorgulu, MD

sevket5@yahoo.com

First Name & Middle Initial & Last Name & Degree

Sevket Gorgulu, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

29667233

Citation

Gorgulu S, Norgaz T, Sipahi I. Ankaferd blood stopper as a new strategy to avoid early complications after transradial procedures: A randomized clinical trial. J Interv Cardiol. 2018 Aug;31(4):511-517. doi: 10.1111/joic.12514. Epub 2018 Apr 17.

Results Reference

derived

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Ankaferd Blood Stopper for Hemostasis After Transradial Coronary Angiography

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