Ankaferd Blood Stopper for Hemostasis After Transradial C... | NCT02982733

Studies
Ankaferd Blood Stopper for Hemostasis After Transradial Coronary Angiography

NCT02982733

Sponsor

Acibadem University

Status

Unknown status

Last Update Posted

Dec 5, 2016Estimated

Enrollment

600Estimated

Phase

Not Applicable

Conditions

Radial Artery Injury
Hematoma
Bleed

Interventions

ABS
TR Band
CS

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Nov 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Nov 23, 2016

First Submission Date that Met QC Criteria

Dec 2, 2016

First Posted Date

Dec 5, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2016

Last Update Posted Date

Dec 5, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ABS	Active Comparator	Ankaferd blood stopper	Other: ABS
CS	Placebo Comparator	Conventional sterile gauze	Other: CS
TR BAND	Active Comparator	Dedicated hemostatic device	Device: TR Band

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ABS	Other	Ankaferd Blood Stopper	ABS
TR Band

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radial artery occlusion assessed by reverse Barbeau's test		24 hours

Secondary Outcomes

Measure	Description	Time Frame
Bleeding	any kind of bleeding defined as ml after the removal of hemostatic dressings or devices	2 hours
Hematoma	hematomas larger then >5cm

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sevket Gorgulu, Prof	Contact	02623174121		sevket5@yahoo.com

Overall Officials

Name	Affiliation	Role
Sevket Gorgulu, Prof	Acibadem University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Acibadem University	Recruiting	Istanbul			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29667233	Derived	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.

Type	Date	Date Unknown
Release	Oct 26, 2017
Reset	Jul 31, 2018
Release	Aug 27, 2018
Reset	Jan 30, 2019

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 26, 2017			Jul 31, 2018
Aug 27, 2018

ID	Term
D006406	Hematoma
D006470	Hemorrhage

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms