Ankaferd Blood Stopper for Hemostasis After Transradial Coronary Angiography
Ankaferd Blood Stopper as a New Strategy to Avoid Early Complication After Transradial Coronary Angiography: A Randomized, Placebo-Controlled Clinical Trial
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 23, 2016
CompletedFirst Posted
Study publicly available on registry
December 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedDecember 5, 2016
December 1, 2016
1 year
November 23, 2016
December 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Radial artery occlusion assessed by reverse Barbeau's test
24 hours
Secondary Outcomes (2)
Bleeding
2 hours
Hematoma
24 hours
Study Arms (3)
ABS
ACTIVE COMPARATORAnkaferd blood stopper
CS
PLACEBO COMPARATORConventional sterile gauze
TR BAND
ACTIVE COMPARATORDedicated hemostatic device
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Acibadem University
Istanbul, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 29667233DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sevket Gorgulu, Prof
Acibadem University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
November 23, 2016
First Posted
December 5, 2016
Study Start
November 1, 2016
Primary Completion
November 1, 2017
Study Completion
December 1, 2017
Last Updated
December 5, 2016
Record last verified: 2016-12