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CompletedNCT03360045Updated Aug 7, 2018

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

A Phase 4 interventional study of Tranexamic Acid and Normal saline in Tranexamic Acid, Epistaxis and Nasal Packing, sponsored by Kecioren Education and Training Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-07.

Sponsored by Kecioren Education and Training Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
135
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Tranexamic Acid
  • Epistaxis
  • Nasal Packing

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03

In context

Epistaxis

96 studies on the registry are indexed under Epistaxis; 22 are open to participants now.

This study's enrollment of 135 is above the median of 64 across 81 interventional studies indexed under Epistaxis.

Browse Epistaxis studies →

Lead sponsor

Kecioren Education and Training Hospital is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
135 participants (actual)

Study arms

  • 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

  • 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

  • Active comparator
    Merocel Group

    Merocel packing is applied.

    Device: Merocel

Interventions

  • 500mg tranexamic acid is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.

  • DrugNormal saline

    5 cc normal saline is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.

  • DeviceMerocel

    Merocel packing is applied.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: First 15 minutes

  2. 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.

    Time frame: After 15 minutes first intervention method.

Secondary outcomes

  1. Re-bleeding

    Frequency of re-bleeding within first 24 hours.

    Time frame: 24 hour

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Study locations

1 site
  • Keçiören Training and Research Hospital
    Ankara, 06000, Turkey
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References and documents

Publications

  • Akkan S, Corbacioglu SK, Aytar H, Emektar E, Dagar S, Cevik Y. Evaluating Effectiveness of Nasal Compression With Tranexamic Acid Compared With Simple Nasal Compression and Merocel Packing: A Randomized Controlled Trial. Ann Emerg Med. 2019 Jul;74(1):72-78. doi: 10.1016/j.annemergmed.2019.03.030. Epub 2019 May 9. PubMed 31080025 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03360045
Lead sponsor
Kecioren Education and Training Hospital
Responsible party
Şeref Kerem Çorbacıoğlu (Associated professor, Kecioren Education and Training Hospital) — Principal investigator
First posted
Dec 2, 2017
Start date
May 1, 2018
Primary completion
Aug 1, 2018
Completion
Aug 1, 2018
Last update
Aug 7, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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