Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06183918
Status:
COMPLETED
Last Update Posted:
2023-12-28
First Post:
2023-07-27
Brief Title:
Tranexamic Acid Dosage for Topical Treatment of Anterior Epistaxis
Sponsor:
Izmir Ataturk Training and Research Hospital
Organization:
Izmir Ataturk Training and Research Hospital
Study Overview
Official Title:
Appropriate Dose Of Tranexamic Acid In The Topical Treatment Of Anterior Epistaxis 500mg Vs 1000mg A Double-Blinded Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Tranexamicacid
Brief 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 mg25 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 andor 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 andor 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
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 mg25 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 andor 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None