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Ankaferd Blood Stopper for Hemostasis After Transradial Coronary Angiography

NCT ID: NCT02982733

Last Updated: 2016-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Radial Artery Injury Hematoma Bleed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ABS

Ankaferd blood stopper

Group Type ACTIVE_COMPARATOR

ABS

Intervention Type OTHER

Ankaferd Blood Stopper

CS

Conventional sterile gauze

Group Type PLACEBO_COMPARATOR

CS

Intervention Type OTHER

Sterile Gauze

TR BAND

Dedicated hemostatic device

Group Type ACTIVE_COMPARATOR

TR Band

Intervention Type DEVICE

Transradial band

Interventions

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ABS

Ankaferd Blood Stopper

Intervention Type OTHER

TR Band

Transradial band

Intervention Type DEVICE

CS

Sterile Gauze

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Sevket Gorgulu

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sevket Gorgulu, Prof

Role: STUDY_CHAIR

Acibadem University

Locations

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Acibadem University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sevket Gorgulu, Prof

Role: CONTACT

Phone: 02623174121

Email: [email protected]

Facility Contacts

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Sevket Gorgulu, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 29667233 (View on PubMed)

Other Identifiers

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ATADEK2016/17-4

Identifier Type: -

Identifier Source: org_study_id