Tranexamic Acid Versus Blood Stopper Treatments in Epistaxis Management

Phase 4

Not yet recruiting

• Conditions: Epistaxis Nosebleed
• Interventions: Drug: Blood Stopper (Ankaferd)

• Registration Number: NCT06490653
• Lead Sponsor: Ankara Ataturk Sanatorium Training and Research Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-29
• Study First Submitted QC: 2024-06-29
• Last Update Submitted: 2024-06-29
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08
• Study Start: 2024-10
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	Blood Stopper (Ankaferd)	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.
Blood Stopper (Ankaferd)	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.

Primary Outcome Measures

Name	Time	Method
Cessation of bleeding	10-minutes after performing local drug interventions.	Primary outcome was definition cessation in bleeding at 10-minutes after performing local drug interventions.

Secondary Outcome Measures

Name	Time	Method
Re-bleeding	From cessation of bleeding to re-bleeding within 24-hours.	The secondary outcome was a comparison of the re-bleeding rate within 24 hours in the two treatments groups.