Ankaferd Blood Stopper for Hemostasis After Transradial Coronary Angiography

Hematoma Clinical Trial

Official title:

Ankaferd Blood Stopper as a New Strategy to Avoid Early Complication After Transradial Coronary Angiography: A Randomized, Placebo-Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02982733
• Other study ID #: ATADEK2016/17-4
• Status: Recruiting
• Phase: N/A
• First received: November 23, 2016
• Last updated: December 2, 2016
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Acibadem University
• Contact: Sevket Gorgulu, Prof
• Phone: 02623174121
• Email: sevket5[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bleed
• Hematoma
• Radial Artery Injury

Intervention

Other:
• ABS
Ankaferd Blood Stopper

Device:
• TR Band
Transradial band

Other:
• CS
Sterile Gauze

Locations

Country	Name	City	State
Turkey	Acibadem University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radial artery occlusion assessed by reverse Barbeau's test		24 hours
Secondary	Bleeding	any kind of bleeding defined as ml after the removal of hemostatic dressings or devices	2 hours
Secondary	Hematoma	hematomas larger then >5cm	24 hours