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

NCT ID: NCT03360045

Last Updated: 2018-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2018-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tranexamic Acid Epistaxis Nasal Packing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tranexamic acid group

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

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

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

Placebo group

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Merocel Group

Merocel packing is applied.

Group Type ACTIVE_COMPARATOR

Merocel

Intervention Type DEVICE

Merocel packing is applied.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tranexamic Acid

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

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Merocel

Merocel packing is applied.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kecioren Education and Training Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Şeref Kerem Çorbacıoğlu

Associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Keçiören Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31080025 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

71146310-511.06-E.223856

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nebulized Tranexamic Acid in Sinus Surgery
NCT04905901 RECRUITING PHASE3