Comparing Effectiveness of Merocel and Packing With Tranexamic Acid in the Management of Anterior Epistaxis

Phase 4

Completed

• Conditions: Tranexamic Acid; Nasal Packing; Epistaxis
• Interventions: Device: Merocel; Drug: Normal saline; Drug: Tranexamic Acid

• Registration Number: NCT03360045
• Lead Sponsor: Kecioren Education and Training Hospital

Brief Summary

Aim of this study is evaluate whether superior nasal compression with tranexamic acid to simple nasal compression and Merocel packing.

In this study, patients who presented with non-traumatic anterior epistaxis to emergency departments will be included in this study. Three different therapy option are created; first, nasal compression with tranexamic acid, second, simple nasal compression without any drugs. And third, packing with Merocel.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-19
• Study First Submitted QC: 2017-11-27
• Study First Posted: 2017-12-02
• Study Start: 2018-05-01
• Status Verified: 2018-08
• Primary Completion: 2018-08-01
• Study Completion: 2018-08-01
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• Patients with anterior epistaxis older than 18 year and accept to participate in the study

Exclusion Criteria

• Patients younger than 18 years
• Patients who used anticoagulation therapy
• Patients who have hemodynamically instability
• Traumatic epistaxis
• Patients who have known bleeding disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Merocel Group	Merocel	Merocel packing is applied.
Placebo group	Normal saline	5ml normal saline is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.
Tranexamic acid group	Tranexamic Acid	500mg tranexamic acid is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.

Primary Outcome Measures

Name	Time	Method
Numbers of patients who needs rescue treatment	After 15 minutes first intervention method.	In patients who have unstoppable epistaxis within 15 minutes, Merocel packing will be applied as a rescue treatment. Numbers of these patients will be recorded.
Success rate of interventions to stop bleeding	First 15 minutes	Percentages of numbers of patients who have stopped bleeding within first 15 minutes after nasal compression or Merocel packing

Secondary Outcome Measures

Name	Time	Method
Re-bleeding	24 hour	Frequency of re-bleeding within first 24 hours.

Trial Locations

Locations (1)

Keçiören Training and Research Hospital; 🇹🇷 Ankara, Turkey