Comparing Effectiveness of Merocel and Packing With Tranexamic Acid in the Management of Anterior Epistaxis
Primary Purpose
Tranexamic Acid, Epistaxis, Nasal Packing
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Tranexamic Acid
Normal saline
Merocel
Sponsored by
About this trial
This is an interventional treatment trial for Tranexamic Acid
Eligibility Criteria
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
Sites / Locations
- Keçiören Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Tranexamic acid group
Placebo group
Merocel Group
Arm Description
500mg tranexamic acid is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.
5ml normal saline is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.
Merocel packing is applied.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Re-bleeding
Frequency of re-bleeding within first 24 hours.
Full Information
NCT ID
NCT03360045
First Posted
November 19, 2017
Last Updated
August 6, 2018
Sponsor
Kecioren Education and Training Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03360045
Brief Title
Comparing Effectiveness of Merocel and Packing With Tranexamic Acid in the Management of Anterior Epistaxis
Official Title
The Evaluation of Effectiveness of Nasal Compression With Tranexamic Acid Compared to Simple Nasal Compression and Merocel Packing
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kecioren Education and Training Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tranexamic Acid, Epistaxis, Nasal Packing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic acid group
Arm Type
Active Comparator
Arm Description
500mg tranexamic acid is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
5ml normal saline is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.
Arm Title
Merocel Group
Arm Type
Active Comparator
Arm Description
Merocel packing is applied.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
500mg tranexamic acid is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
5 cc normal saline is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.
Intervention Type
Device
Intervention Name(s)
Merocel
Intervention Description
Merocel packing is applied.
Primary Outcome Measure Information:
Title
Success rate of interventions to stop bleeding
Description
Percentages of numbers of patients who have stopped bleeding within first 15 minutes after nasal compression or Merocel packing
Time Frame
First 15 minutes
Title
Numbers of patients who needs rescue treatment
Description
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 Outcome Measure Information:
Title
Re-bleeding
Description
Frequency of re-bleeding within first 24 hours.
Time Frame
24 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Keçiören Training and Research Hospital
City
Ankara
ZIP/Postal Code
06000
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
31080025
Citation
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.
Results Reference
derived
Learn more about this trial
Comparing Effectiveness of Merocel and Packing With Tranexamic Acid in the Management of Anterior Epistaxis
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