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

• Sponsor: Kecioren Education and Training Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03360045
• Collaborator: (none)
• Enrollment: 135
• Location: 1
• Arms: 3
• Actual Duration (Months): 3
• Patients Per Site Per Month: 44.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tranexamic Acid; Epistaxis; Nasal Packing	Drug: Tranexamic Acid; Drug: Normal saline; Device: Merocel	Phase 4

Study Design

• Study Type: Interventional
• 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: Aug 1, 2018
• Actual Study Completion Date: Aug 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Success rate of interventions to stop bleeding [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 [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 [24 hour]

   Frequency of re-bleeding within first 24 hours.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keçiören Training and Research Hospital	Ankara		Turkey	06000

Sponsors and Collaborators

• Kecioren Education and Training Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Dec 2, 2017
• Last Update Posted: Aug 7, 2018
• Last Verified: Aug 1, 2018

• 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: Epistaxis; Tranexamic Acid; Polyvinyl alcohol formaldehyde foam

Study Results

No Results Posted as of Aug 7, 2018