Tranexamic Acid Dosage for Topical Treatment of Anterior Epistaxis
Condition: Anterior Epistaxis; Tranexamic Acid
MeSH terms: Epistaxis
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This randomized, double-blinded, phase-4 study was conducted in a single center between July
      and December 2022.

      Among the patients aged 18 years and older who applied to the emergency department with
      epistaxis that accepted to participate in the study and could give written consent, patients
      with posterior epistaxis, with a history of nose or pharynx surgery in the last 3 months,
      with facial and head trauma, with unstable vital signs, patients who applied for the second
      time with a recurrent bleeding, patients with a history of allergy to TXA, patients with
      subarachnoid hemorrhage, patients with coagulation disorders such as hemophilia, hereditary
      telangiectasia, von Willebrand disease, etc., patients with thromboembolic disease, history
      of convulsions or intracerebral processes, and those who were pregnant or lactating, and who
      wished to withdraw from the study at any stage of the study were excluded from the study. 152
      patients who did not meet the exclusion criteria were included in the study.

      In this 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. Physicians and nurses participating in the study were given a total of 2
      hours of theoretical and practical training on the design of the study and nasal packing
      application before the study. 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. 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 ANP 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 (CRF). It was checked whether the bleeding continued at
           the 5th and 10th minutes after ANP and medication administration. In cases of bleeding
           lasting longer than ten minutes, one of the standard treatments used in epistaxis
           treatment (Sponge-shaped nasal tampon or inflatable balloon-shaped nasal tampon) was
           applied as salvage therapy, and otorhinolaryngology consultation was requested when
           necessary. In addition, patients were followed up for at least 1 hour in terms of
           possible side effects. Demographic data (age, gender), vital signs, use of anticoagulant
           and/or antiplatelet drugs, hemoglobin (Hgb), platelet (Plt), and International
           Normalized Ratio (INR) values of the cases, data of the applied procedure (5th and 10th
           minute bleeding control, necessity of salvage therapy), treatment-related side effects
           (administration site reaction, rash, rash, itching, erythema, urticaria, hives, chest
           pain, dyspnea, nausea, vomiting, blackout, headache, dizziness), the need for
           otorhinolaryngology consultation, and whether recurrency developed within 24 hours was
           recorded in the CRF. Participants were advised to inform the principal investigator by
           telephone if recurrent bleeding occurs within 24 hours and to apply to the emergency
           department again in case of recurrent and/or prolonged bleeding.

      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.
    

Intervention name(s): Tranexamic acid; Saline
Intervention type(s): Drug; Other
Intervention description(s): Group: Gauze soaked with 1000 mg TXA-topical
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.; 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.
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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;
Group: Gauze soaked with 1000 mg TXA-topical
Group: Gauze soaked with 500 mg TXA + 5 cc saline -topical
Group: Gauze soaked with 10 cc of saline-topical.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anterior epistaxis; Tranexamic acid; Topical treatment; Emergency medicine