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

Epistaxis Clinical Trial

Official title:

The Evaluation of Effectiveness of Nasal Compression With Tranexamic Acid Compared to Simple Nasal Compression and Merocel Packing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03360045
• Other study ID #: 71146310-511.06-E.223856
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2018
• Source: Kecioren Education and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Epistaxis
• Nasal Packing
• Tranexamic Acid

Intervention

Drug:
• Tranexamic Acid
500mg tranexamic acid is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.
• Normal saline
5 cc normal saline is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.

Device:
• Merocel
Merocel packing is applied.

Locations

Country	Name	City	State
Turkey	Keçiören Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Kecioren Education and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of interventions to stop bleeding	Percentages of numbers of patients who have stopped bleeding within first 15 minutes after nasal compression or Merocel packing	First 15 minutes
Primary	Numbers of patients who needs rescue treatment	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.	After 15 minutes first intervention method.
Secondary	Re-bleeding	Frequency of re-bleeding within first 24 hours.	24 hour