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Status unknownNCT02982733Updated Dec 5, 2016

Ankaferd Blood Stopper for Hemostasis After Transradial Coronary Angiography

An interventional study of ABS and TR Band in Radial Artery Injury, Hematoma and Bleed, sponsored by Acibadem University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-05.

Sponsored by Acibadem University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Radial Artery Injury
  • Hematoma
  • Bleed

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03

In context

Hematoma

247 studies on the registry are indexed under Hematoma; 54 are open to participants now.

This study's planned enrollment of 600 is above the median of 100 across 173 interventional studies indexed under Hematoma.

Browse Hematoma studies →

Lead sponsor

Acibadem University is the lead sponsor of 210 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Active comparator
    ABS

    Ankaferd blood stopper

    Other: ABS

  • Placebo comparator
    CS

    Conventional sterile gauze

    Other: CS

  • Active comparator
    TR BAND

    Dedicated hemostatic device

    Device: TR Band

Interventions

  • OtherABS

    Ankaferd Blood Stopper

  • DeviceTR Band

    Transradial band

  • OtherCS

    Sterile Gauze

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What researchers measure

Primary outcomes

  1. Radial artery occlusion assessed by reverse Barbeau's test

    Time frame: 24 hours

Secondary outcomes

  1. Bleeding

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

    Time frame: 2 hours

  2. Hematoma

    hematomas larger then \>5cm

    Time frame: 24 hours

07

Study locations

1 of 1 sites recruiting
  • Acibadem University
    İstanbul, Turkey
    • Sevket Gorgulu, MD · Contact · sevket5@yahoo.com
    • Sevket Gorgulu, MD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 29667233 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02982733
Lead sponsor
Acibadem University
Responsible party
Sevket Gorgulu (Prof. Dr., Acibadem University) — Principal investigator
First posted
Dec 5, 2016
Start date
Nov 2016
Primary completion
Nov 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Dec 5, 2016

Study contacts

Sevket Gorgulu, Prof
Contact
sevket5@yahoo.com
02623174121
Sevket Gorgulu, Prof
study chair · Acibadem University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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