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Tranexamic Acid Dosage for Topical Treatment of Anterior Epistaxis

NCT06183918 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2023-12-28

No results posted yet for this study

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

Interventions

DRUG

Tranexamic acid

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.

OTHER

Saline

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.

Sponsors & Collaborators

  • Izmir Ataturk Training and Research Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
92 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-16
Primary Completion
2022-12-31
Completion
2023-03-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06183918 on ClinicalTrials.gov