Ankaferd Blood Stopper for Hemostasis After Transradial Coronary Angiography

Acibadem University

Status: Unknown

Conditions: Bleed; Radial Artery Injury; Hematoma

Treatments: Other: CS; Other: ABS; Device: TR Band

Study type: Interventional

Funder types: Other

Identifiers

NCT02982733

ATADEK2016/17-4

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups, including a placebo group

ABS

Active Comparator group

Description:

Ankaferd blood stopper

Treatment:

Other: ABS

CS

Placebo Comparator group

Description:

Conventional sterile gauze

Treatment:

Other: CS

TR BAND

Active Comparator group

Description:

Dedicated hemostatic device

Treatment:

Device: TR Band