Radial Artery InjuryNCT02982733
Ankaferd Blood Stopper for Hemostasis After Transradial Coronary Angiography
A study testing ABS, TR Band and CS in people with Radial Artery Injury and Hematoma, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Injury, Hematoma, Bleed
- What is being tested?
- ABS, TR Band and CS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The only exclusion criteria were an abnormal Barbeau's test before puncture and failure to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem University
Istanbul
Sevket Gorgulu, MD, sevket5@yahoo.com
Sevket Gorgulu, MD
About this study
Official title: Ankaferd Blood Stopper as a New Strategy to Avoid Early Complication After Transradial Coronary Angiography: A Randomized, Placebo-Controlled Clinical Trial
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.
- Conditions
- Radial Artery Injury, Hematoma, Bleed
- Being tested
- ABS, TR Band, CS
- Medical subject headings
- Hematoma, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSOther
Ankaferd Blood Stopper
TR BandDevice
Transradial band
CSOther
Sterile Gauze
| Study group | Role | What they receive |
|---|---|---|
| ABS | Active comparator | Ankaferd blood stopper Receives: Other: ABS |
| CS | Placebo comparator | Conventional sterile gauze Receives: Other: CS |
| TR BAND | Active comparator | Dedicated hemostatic device Receives: Device: TR Band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial artery occlusion assessed by reverse Barbeau's test
Measured: 24 hours
Secondary outcomes (2)
Bleeding
any kind of bleeding defined as ml after the removal of hemostatic dressings or devices
Measured: 2 hours
Hematoma
hematomas larger then >5cm
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radial Artery InjuryStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevket Gorgulu, Acibadem University
- Investigators
- Sevket Gorgulu, Prof, Study chair, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982733
- Sponsor's protocol ID
- ATADEK2016/17-4
- Status last verified
- Dec 2016
- First submitted
- 23 Nov 2016
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankaferd Blood Stopper as a New Strategy to Avoid Early Complication After Transradial Coronary Angiography: A Randomized, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02982733
- Acronym / sponsor ID
- ATADEK2016/17-4
- Conditions
- Radial Artery Injury, Hematoma, Bleed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABS | Active comparator | Other: ABSAnkaferd blood stopper |
| CS | Placebo comparator | Other: CSConventional sterile gauze |
| TR BAND | Active comparator | Device: TR BandDedicated hemostatic device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- The only exclusion criteria were an abnormal Barbeau's test before puncture and failure to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABSAnkaferd Blood Stopper | Other | ABS |
| TR BandTransradial band | Device | TR BAND |
| CSSterile Gauze | Other | CS |
Primary outcome
Radial artery occlusion assessed by reverse Barbeau's test
Time frame: 24 hours
2 secondary outcomes
Bleeding
Time frame: 2 hours
Hematoma
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- Derived from this study: PubMed 29667233Gorgulu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevket Gorgulu, Prof study chair
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABS, TR Band and CS in people with Radial Artery Injury and Hematoma, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sevket Gorgulu, Prof (02623174121, sevket5@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial artery occlusion assessed by reverse Barbeau's test (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02982733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.