Tranexamic Acid Versus Blood Stopper Treatments in Epistaxis Management

Ankara Ataturk Sanatorium Training and Research Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Epistaxis Nosebleed

Treatments: Drug: Blood Stopper (Ankaferd)

Study type: Interventional

Funder types: Other

Identifiers

NCT06490653

AEŞH-EK1-2024-0048

Details and patient eligibility

About

In this randonmized controlled trial, aim to compare the effectiveness of local administration of tranexamic acid and blood stopper (Ankaferd®) on cessation of bleeding in epistaxis patients.

Full description

Anterior tamponade is frequently used in the management of anterior epistaxis. However, this procedure is often uncomfortable for patients. Therefore, instead of this physical tampon, various pharmacologic agents such as tranexamic acid, blood stoppers (ankaferd®), and adrenaline can be used in epistaxis management. Although the superiority of various agents used in the management of anterior epistaxis has been evaluated in published network meta-analyses, these meta-analyses do not compare ankaferd and Tranexamic acid since there are no studies with each other. In order to close the gap in the existing literature, this study aims to evaluate the superiority of local administration of tranexamic acid and ankaferd® in terms of cessation of bleeding in patients with anterior epistaxis.

Enrollment: 186 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years of age with epistaxis will present to the emergency department with non-traumatic epistaxis and whose bleeding do not stop with simple external compression for 10 minutes.

Exclusion criteria

• Patients demonstrating hemodynamic instability
• Patients with documented allergy to tranexamic acid or Ankaferd
• patients with known bleeding disorders,
• patients using anticoagulants,
• pregnant patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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186 participants in 2 patient groups

Tranexamic acid

Active Comparator group

Description:

Patients will be asked to clean their nose with tap water as part of the routine treatment before the administration. After then, Tranexamic acid (500mg/5 ml) will be sprayed through the bleeding side nostril and then external pressure will be applied to the nose for 10 minutes.

Treatment:

Drug: Blood Stopper (Ankaferd)

Blood Stopper (Ankaferd)

Experimental group

Description:

Patients will be asked to clean their noses with tap water as part of the routine treatment before the administration. After then, 5 ml of Ankaferd® will be sprayed through the bleeding side nostril and external nasal pressure will be performed for 10 minutes.

Treatment:

Drug: Blood Stopper (Ankaferd)