Comparison of the Efficacy of Tranexamic Acid and Blood Stopper Treatments in Bleeding Control in Patients With Epistaxis: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 186
- Primary Endpoint
- Cessation of bleeding
Study Overview
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.
Detailed Description
Anterior tamponade is frequently used in the management of anterior epistaxis. However, this procedure is often uncomfortable for patients. Therefore, instead of this physical tampon, various pharmacologic agents such as tranexamic acid, blood stoppers (ankaferd®), and adrenaline can be used in epistaxis management. Although the superiority of various agents used in the management of anterior epistaxis has been evaluated in published network meta-analyses, these meta-analyses do not compare ankaferd and Tranexamic acid since there are no studies with each other. In order to close the gap in the existing literature, this study aims to evaluate the superiority of local administration of tranexamic acid and ankaferd® in terms of cessation of bleeding in patients with anterior epistaxis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients demonstrating hemodynamic instability
- •Patients with documented allergy to tranexamic acid or Ankaferd
- •patients with known bleeding disorders,
- •patients using anticoagulants,
- •pregnant patients
Arms & Interventions
Tranexamic acid
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.
Intervention: Blood Stopper (Ankaferd) (Drug)
Blood Stopper (Ankaferd)
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.
Intervention: Blood Stopper (Ankaferd) (Drug)
Outcomes
Primary Outcomes
Cessation of bleeding
Time Frame: 10-minutes after performing local drug interventions.
Primary outcome was definition cessation in bleeding at 10-minutes after performing local drug interventions.
Secondary Outcomes
- Re-bleeding(From cessation of bleeding to re-bleeding within 24-hours.)
Investigators
Şeref Kerem Çorbacıoğlu
Emergency Medicine Department
Ankara Ataturk Sanatorium Training and Research Hospital