Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06183918 |
| Other study ID # |
IzmirATRH |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
December 16, 2021 |
| Est. completion date |
March 15, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
Izmir Ataturk Training and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
