Epistaxis NosebleedPhase 4NCT06490653
Tranexamic Acid Versus Blood Stopper Treatments in Epistaxis Management
A Phase 4 study testing Blood Stopper (Ankaferd) in people with Epistaxis Nosebleed, run by Ankara Ataturk Sanatorium Training and Research Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epistaxis Nosebleed
- What is being tested?
- Blood Stopper (Ankaferd)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients demonstrating hemodynamic instability
- Patients with documented allergy to tranexamic acid or Ankaferd
- patients with known bleeding disorders,
- patients using anticoagulants,
- pregnant patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Efficacy of Tranexamic Acid and Blood Stopper Treatments in Bleeding Control in Patients With Epistaxis: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Epistaxis Nosebleed
- Being tested
- Blood Stopper (Ankaferd)
- Keywords
- Epistaxis, Nosebleed, Ankaferd, Tranexamic acid
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Stopper (Ankaferd)Drug
5 ml of Ankaferd® will be sprayed through the bleeding side nostril and external nasal pressure will be performed for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Active comparator | 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. Receives: Drug: Blood Stopper (Ankaferd) |
| Blood Stopper (Ankaferd) | Experimental | 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. Receives: Drug: Blood Stopper (Ankaferd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cessation of bleeding
Primary outcome was definition cessation in bleeding at 10-minutes after performing local drug interventions.
Measured: 10-minutes after performing local drug interventions.
Secondary outcomes (1)
Re-bleeding
The secondary outcome was a comparison of the re-bleeding rate within 24 hours in the two treatments groups.
Measured: From cessation of bleeding to re-bleeding within 24-hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epistaxis NosebleedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, there are two parallel treatment arms (tranexamic acid and blood stopper (Ankaferd®) determined by randomization
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Şeref Kerem Çorbacıoğlu, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490653
- Sponsor's protocol ID
- AEŞH-EK1-2024-0048
- Status last verified
- Jun 2024
- First submitted
- 29 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Tranexamic Acid and Blood Stopper Treatments in Bleeding Control in Patients With Epistaxis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06490653
- Acronym / sponsor ID
- AEŞH-EK1-2024-0048
- Conditions
- Epistaxis Nosebleed
- Keywords
- Epistaxis, Nosebleed, Ankaferd, Tranexamic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In this study, there are two parallel treatment arms (tranexamic acid and blood stopper (Ankaferd®) determined by randomization
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Active comparator | Drug: Blood Stopper (Ankaferd)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. |
| Blood Stopper (Ankaferd) | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- Patients demonstrating hemodynamic instability
- Patients with documented allergy to tranexamic acid or Ankaferd
- patients with known bleeding disorders,
- patients using anticoagulants,
- pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Stopper (Ankaferd)5 ml of Ankaferd® will be sprayed through the bleeding side nostril and external nasal pressure will be performed for 10 minutes. | Drug | Blood Stopper (Ankaferd), Tranexamic acid |
Primary outcome
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.
1 secondary outcome
Re-bleeding
Time frame: From cessation of bleeding to re-bleeding within 24-hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood Stopper (Ankaferd) in people with Epistaxis Nosebleed, run by Ankara Ataturk Sanatorium Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Şeref Kerem Çorbacıoğlu, Professor (+905437656176, serefkeremcorbacioglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cessation of bleeding (time frame: 10-minutes after performing local drug interventions.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.