Tranexamic Acid Versus Blood Stopper Treatments in Epistaxis Management

NCT06490653 | Not Yet Recruiting Phase 4

• 1 other identifier: AEŞH-EK1-2024-0048
• Study Type: interventional
• Target: 186
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this randonmized controlled trial, aim to compare the effectiveness of local administration of tranexamic acid and blood stopper (Ankaferd®) on cessation of bleeding in epistaxis patients.

Conditions

Epistaxis Nosebleed

Keywords

Epistaxis; Nosebleed; Ankaferd; Tranexamic acid

Outcome Measures

Primary Outcomes (1)

• Cessation of bleeding

  Primary outcome was definition cessation in bleeding at 10-minutes after performing local drug interventions.

  10-minutes after performing local drug interventions.

Secondary Outcomes (1)

• Re-bleeding

  From cessation of bleeding to re-bleeding within 24-hours.

Study Arms (2)

Tranexamic acid

ACTIVE COMPARATOR

Patients will be asked to clean their nose with tap water as part of the routine treatment before the administration. After then, Tranexamic acid (500mg/5 ml) will be sprayed through the bleeding side nostril and then external pressure will be applied to the nose for 10 minutes.

Drug: Blood Stopper (Ankaferd)

Blood Stopper (Ankaferd)

EXPERIMENTAL

Patients will be asked to clean their noses with tap water as part of the routine treatment before the administration. After then, 5 ml of Ankaferd® will be sprayed through the bleeding side nostril and external nasal pressure will be performed for 10 minutes.

Drug: Blood Stopper (Ankaferd)

Interventions

Blood Stopper (Ankaferd) DRUG

5 ml of Ankaferd® will be sprayed through the bleeding side nostril and external nasal pressure will be performed for 10 minutes.

Blood Stopper (Ankaferd); Tranexamic acid

Eligibility Criteria

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

You may qualify if:

• Patients over 18 years of age with epistaxis will present to the emergency department with non-traumatic epistaxis and whose bleeding do not stop with simple external compression for 10 minutes.

You may not qualify if:

• Patients demonstrating hemodynamic instability
• Patients with documented allergy to tranexamic acid or Ankaferd
• patients with known bleeding disorders,
• patients using anticoagulants,
• pregnant patients

Sponsors & Collaborators

• Ankara Ataturk Sanatorium Training and Research Hospital: lead

MeSH Terms

Conditions

Epistaxis

Interventions

ankaferd blood stopper

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Şeref Kerem Çorbacıoğlu, Professor

CONTACT

+905437656176; serefkeremcorbacioglu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study was designed so that patients and researchers in all roles (care provider, outcome assessor, and statistician) were masked to the treatment arms. Following the enrolment, the principal investigator will be contacted to find out which treatment arm the patient will be enrolled in according to the predetermined order. According to the assigned treatment arm, the relevant treatment will be prepared by another researcher in a physically non-distinguishable. A care provider will administer the prepared treatment and assess whether bleeding has stopped approximately 10 minutes after administration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Department

Model Details: In this study, there are two parallel treatment arms (tranexamic acid and blood stopper (Ankaferd®) determined by randomization

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 8, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share