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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03360045
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Şeref Kerem Çorbacıoğlu, Kecioren Education and Training Hospital

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.


Condition or disease Intervention/treatment Phase
Tranexamic Acid Epistaxis Nasal Packing Drug: Tranexamic Acid Drug: Normal saline Device: Merocel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Evaluation of Effectiveness of Nasal Compression With Tranexamic Acid Compared to Simple Nasal Compression and Merocel Packing
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Re-bleeding [ Time Frame: 24 hour ]
    Frequency of re-bleeding within first 24 hours.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360045


Locations
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Turkey
Keçiören Training and Research Hospital
Ankara, Turkey, 06000
Sponsors and Collaborators
Kecioren Education and Training Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Şeref Kerem Çorbacıoğlu, Associated professor, Kecioren Education and Training Hospital
ClinicalTrials.gov Identifier: NCT03360045    
Other Study ID Numbers: 71146310-511.06-E.223856
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018

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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
Additional relevant MeSH terms:
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Epistaxis
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes
Signs and Symptoms, Respiratory
Tranexamic Acid
Polyvinyl alcohol formaldehyde foam
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants