Tranexamic Acid Versus Blood Stopper Treatments in Epistaxis Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Epistaxis Nosebleed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In this study, there are two parallel treatment arms (tranexamic acid and blood stopper (Ankaferd®) determined by randomization

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The study was designed so that patients and researchers in all roles (care provider, outcome assessor, and statistician) were masked to the treatment arms. Following the enrolment, the principal investigator will be contacted to find out which treatment arm the patient will be enrolled in according to the predetermined order. According to the assigned treatment arm, the relevant treatment will be prepared by another researcher in a physically non-distinguishable. A care provider will administer the prepared treatment and assess whether bleeding has stopped approximately 10 minutes after administration.

Study Groups

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Tranexamic acid

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.

Group Type ACTIVE_COMPARATOR

Blood Stopper (Ankaferd)

Intervention Type DRUG

5 ml of Ankaferd® will be sprayed through the bleeding side nostril and external nasal pressure will be performed for 10 minutes.

Blood Stopper (Ankaferd)

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.

Group Type EXPERIMENTAL

Blood Stopper (Ankaferd)

Intervention Type DRUG

5 ml of Ankaferd® will be sprayed through the bleeding side nostril and external nasal pressure will be performed for 10 minutes.

Interventions

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Blood Stopper (Ankaferd)

5 ml of Ankaferd® will be sprayed through the bleeding side nostril and external nasal pressure will be performed for 10 minutes.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No