Epistaxis Nosebleed
Conditions
Keywords
Epistaxis, Nosebleed, Ankaferd, Tranexamic acid
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.
Interventions
DRUGBlood Stopper (Ankaferd)
5 ml of Ankaferd® will be sprayed through the bleeding side nostril and external nasal pressure will be performed for 10 minutes.
Sponsors
Ankara Ataturk Sanatorium Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
In this study, there are two parallel treatment arms (tranexamic acid and blood stopper (Ankaferd®) determined by randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cessation of bleeding | 10-minutes after performing local drug interventions. | Primary outcome was definition cessation in bleeding at 10-minutes after performing local drug interventions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Re-bleeding | From cessation of bleeding to re-bleeding within 24-hours. | The secondary outcome was a comparison of the re-bleeding rate within 24 hours in the two treatments groups. |
Contacts
Primary ContactŞeref Kerem Çorbacıoğlu, Professor
Outcome results
None listed