NCT03360045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

November 19, 2017

Last Update Submit

August 6, 2018

Conditions

Tranexamic AcidEpistaxisNasal Packing

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Re-bleeding

    24 hour

Study Arms (3)

Tranexamic acid group

ACTIVE COMPARATOR

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

Drug: Tranexamic Acid

Placebo group

PLACEBO COMPARATOR

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

Drug: Normal saline

Merocel Group

ACTIVE COMPARATOR

Merocel packing is applied.

Device: Merocel

Interventions

Tranexamic AcidDRUG

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

Tranexamic acid group
Normal salineDRUG

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

Placebo group
MerocelDEVICE

Merocel packing is applied.

Merocel Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keçiören Training and Research Hospital

Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 31080025DERIVED

MeSH Terms

Conditions

Epistaxis

Interventions

Tranexamic AcidSaline Solution

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

November 19, 2017

First Posted

December 2, 2017

Study Start

May 1, 2018

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations

TU(1)