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

August 6, 2018 updated by: Şeref Kerem Çorbacıoğlu, Kecioren Education and Training Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06000
        • Keçiören Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Tranexamic acid group
500mg tranexamic acid is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.
Drug: Tranexamic Acid
500mg tranexamic acid is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.
PLACEBO_COMPARATOR: Placebo group
5ml normal saline is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.
Drug: Normal saline
5 cc normal saline is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.
ACTIVE_COMPARATOR: Merocel Group
Merocel packing is applied.
Device: Merocel
Merocel packing is applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of interventions to stop bleeding
Time Frame: First 15 minutes
Percentages of numbers of patients who have stopped bleeding within first 15 minutes after nasal compression or Merocel packing
First 15 minutes
Numbers of patients who needs rescue treatment
Time Frame: 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.
After 15 minutes first intervention method.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-bleeding
Time Frame: 24 hour
Frequency of re-bleeding within first 24 hours.
24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kecioren Education and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2018

Primary Completion (ACTUAL)

August 1, 2018

Study Completion (ACTUAL)

August 1, 2018

Study Registration Dates

First Submitted

November 19, 2017

First Submitted That Met QC Criteria

November 27, 2017

First Posted (ACTUAL)

December 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71146310-511.06-E.223856

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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