Tranexamic Acid Dosage for Topical Treatment of Anterior Epistaxis

NCT06183918 | Completed Phase 4

• 1 other identifier: IzmirATRH
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with epistaxis usually apply to the emergency department for initial treatment. According to recent research, tranexamic acid is effective in the treatment of epistaxis. The research compare the therapeutic superiority of saline with 500 and 1000 mg doses of topical tranexamic acid in the treatment of anterior epistaxis. The design of the phase 4 clinical trial was randomized controlled double-blind. A total of 152 cases in 3 groups were included in the study. Group 1 was treated with 1000 mg of tranexamic acid, group 2 with 500 mg of tranexamic acid, and group 3 with saline. The primary outcome of the study was bleeding control at the 5th and 10th minutes. Secondary outcomes were determined as the need for salvage therapy, recurrent bleeding within 24 hours, the presence of side effects, and the need for otorhinolaryngology consultation.

Conditions

Anterior Epistaxis; Tranexamic Acid

Keywords

Anterior epistaxis; Tranexamic acid; Topical treatment; Emergency medicine

Outcome Measures

Primary Outcomes (1)

• Number of cases whose nosebleeds were completely stopped

  Number of cases in which nosebleeds were completely stopped at the 5th and 10th minutes

  5th and 10th minutes

Secondary Outcomes (4)

• Need for salvage therapy

  After 10 minutes

• The presence of side effects

  1 hour

• Need for otorhinolaryngology consultation

  After 1 hour

• Recurrent bleeding within 24 hours

  24 hours

Study Arms (3)

1. Group

ACTIVE COMPARATOR

Gauze soaked with 1000 mg TXA-topical

Drug: Tranexamic acid

2. Group

ACTIVE COMPARATOR

Gauze soaked with 500 mg TXA + 5 cc saline -topical

Drug: Tranexamic acid

3. Group

ACTIVE COMPARATOR

Gauze soaked with 10 cc of saline-topical.

Other: Saline

Interventions

Tranexamic acid DRUG

1. Group: Gauze soaked with 1000 mg TXA-topical 2. Group: Gauze soaked with 500 mg TXA + 5 cc saline -topical The prepared anterior nasal packing and medication administration were performed. Pressure was applied to both sides of the nose wings during the application for 10 minutes. It was checked whether the bleeding continued at the 5th and 10th minutes after anterior nasal packing and medication administration.

1. Group; 2. Group

Saline OTHER

3\. Group: Gauze soaked with 10 cc of saline-topical. The prepared anterior nasal packing and medication administration were performed. Pressure was applied to both sides of the nose wings during the application for 10 minutes. It was checked whether the bleeding continued at the 5th and 10th minutes after anterior nasal packing and medication administration.

3. Group

Eligibility Criteria

• Age: 18 Years - 92 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Those who applied to the emergency department with the complaint of nosebleeds
• Those who agreed to participate in the study by giving written consent

You may not qualify if:

• posterior epistaxis
• history of nose or pharynx surgery in the last 3 months,
• facial and head trauma,
• unstable vital signs,
• who applied for the second time with a recurrent bleeding
• history of allergy to TXA,
• subarachnoid hemorrhage,
• coagulation disorders such as hemophilia, hereditary telangiectasia, von Willebrand disease, etc.
• thromboembolic disease
• history of convulsions
• intracerebral processes
• pregnant or lactating
• who wished to withdraw from the study at any stage of the study

Sponsors & Collaborators

• Izmir Ataturk Training and Research Hospital: lead

Study Sites (1)

Ataturk 'Training and Research Hospital

Izmir, Basın Sitesi, 35360, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Tranexamic Acid; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research products, saline and tranexamic acid ampoules containing 250 mg/2.5 ml of injectable solution, both in colorless, odorless, clean, and clear liquid form. The medications and medical supplies (gauze soaked with saline and TXA) to be used in the treatment according to the randomization number were prepared by a physician and a nurse working in the emergency room that were informed about the research priorly. Blindness was ensured by filling all groups to a 10 cc volume with saline. The prepared anterior nasal packing and medication administration were performed blindly by another emergency physician. Pressure was applied to both sides of the nose wings during the application for 10 minutes. Another researcher, who was not responsible for the preparation and administration of the medication, recorded the data in the Case Report Form.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This randomized, double-blinded, phase-4 study. 3 different materials used to soak the gauze in nasal packing with gauze application, which is a treatment method for anterior epistaxis, were compared in terms of their superiority. First, those who met the study criteria and accepted to participate in the study and whose written consent was obtained were assigned to one of the treatment groups according to the next randomization number. Treatment groups were determined as; 1. Group: Gauze soaked with 1000 mg TXA-topical 2. Group: Gauze soaked with 500 mg TXA + 5 cc saline -topical 3. Group: Gauze soaked with 10 cc of saline-topical.

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: December 28, 2023
• Study Start: December 16, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 15, 2023
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 5 years

Locations

TU (1)