Tranexamic AcidPhase 4NCT03360045
Comparing Effectiveness of Merocel and Packing With Tranexamic Acid in the Management of Anterior Epistaxis
A Phase 4 study testing Tranexamic Acid, Normal saline and Merocel in people with Tranexamic Acid and Epistaxis, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aim of this study is evaluate whether superior nasal compression with tranexamic acid to simple nasal compression and Merocel packing. In this study, patients who presented with non-traumatic anterior epistaxis to emergency departments will be included in this study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tranexamic Acid, Epistaxis, Nasal Packing
- What is being tested?
- Tranexamic Acid, Normal saline and Merocel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 1 Aug 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with anterior epistaxis older than 18 year and accept to participate in the study
Who cannot join
- Patients younger than 18 years
- Patients who used anticoagulation therapy
- Patients who have hemodynamically instability
- Traumatic epistaxis
- Patients who have known bleeding disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Keçiören Training and Research Hospital
Ankara, 06000
About this study
Official title: The Evaluation of Effectiveness of Nasal Compression With Tranexamic Acid Compared to Simple Nasal Compression and Merocel Packing
Aim of this study is evaluate whether superior nasal compression with tranexamic acid to simple nasal compression and Merocel packing.
In this study, patients who presented with non-traumatic anterior epistaxis to emergency departments will be included in this study. Three different therapy option are created; first, nasal compression with tranexamic acid, second, simple nasal compression without any drugs. And third, packing with Merocel.
- Conditions
- Tranexamic Acid, Epistaxis, Nasal Packing
- Being tested
- Tranexamic Acid, Normal saline, Merocel
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
500mg tranexamic acid is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.
Normal salineDrug
5 cc normal saline is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.
MerocelDevice
Merocel packing is applied.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid group | Active comparator | 500mg tranexamic acid is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually. Receives: Drug: Tranexamic Acid |
| Placebo group | Placebo comparator | 5ml normal saline is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually. Receives: Drug: Normal saline |
| Merocel Group | Active comparator | Merocel packing is applied. Receives: Device: Merocel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of interventions to stop bleeding
Percentages of numbers of patients who have stopped bleeding within first 15 minutes after nasal compression or Merocel packing
Measured: First 15 minutes
Numbers of patients who needs rescue treatment
In patients who have unstoppable epistaxis within 15 minutes, Merocel packing will be applied as a rescue treatment. Numbers of these patients will be recorded.
Measured: After 15 minutes first intervention method.
Secondary outcomes (1)
Re-bleeding
Frequency of re-bleeding within first 24 hours.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 May 2018
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tranexamic AcidStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kecioren Education and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeref Kerem Çorbacıoğlu, Kecioren Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360045
- Sponsor's protocol ID
- 71146310-511.06-E.223856
- Status last verified
- Aug 2018
- First submitted
- 19 Nov 2017
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akkan S, Corbacioglu SK, Aytar H, Emektar E, Dagar S, Cevik Y. Evaluating Effectiveness of Nasal Compression With Tranexamic Acid Compared With Simple Nasal Compression and Merocel Packing: A Randomized Controlled Trial. Ann Emerg Med. 2019 Jul;74(1):72-78. doi: 10.1016/j.annemergmed.2019.03.030. Epub 2019 May 9.
PubMed 31080025
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Effectiveness of Nasal Compression With Tranexamic Acid Compared to Simple Nasal Compression and Merocel Packing
- ClinicalTrials.gov ID
- NCT03360045
- Acronym / sponsor ID
- 71146310-511.06-E.223856
- Conditions
- Tranexamic Acid, Epistaxis, Nasal Packing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Kecioren Education and Training HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 2 Dec 2017 (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.
Aim of this study is evaluate whether superior nasal compression with tranexamic acid to simple nasal compression and Merocel packing.
In this study, patients who presented with non-traumatic anterior epistaxis to emergency departments will be included in this study. Three different therapy option are created; first, nasal compression with tranexamic acid, second, simple nasal compression without any drugs. And third, packing with Merocel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid group | Active comparator | Drug: Tranexamic Acid500mg tranexamic acid is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually. |
| Placebo group | Placebo comparator | Drug: Normal saline5ml normal saline is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually. |
| Merocel Group | Active comparator | Device: MerocelMerocel packing is applied. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with anterior epistaxis older than 18 year and accept to participate in the study
Key exclusion criteria (5 listed)
- Patients younger than 18 years
- Patients who used anticoagulation therapy
- Patients who have hemodynamically instability
- Traumatic epistaxis
- Patients who have known bleeding disorder
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 |
|---|---|---|
| Tranexamic Acid500mg tranexamic acid is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually. | Drug | Tranexamic acid group |
| Normal saline5 cc normal saline is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually. | Drug | Placebo group |
| MerocelMerocel packing is applied. | Device | Merocel Group |
Primary outcome
Success rate of interventions to stop bleeding
Time frame: First 15 minutes
Percentages of numbers of patients who have stopped bleeding within first 15 minutes after nasal compression or Merocel packing
Numbers of patients who needs rescue treatment
Time frame: After 15 minutes first intervention method.
In patients who have unstoppable epistaxis within 15 minutes, Merocel packing will be applied as a rescue treatment. Numbers of these patients will be recorded.
1 secondary outcome
Re-bleeding
Time frame: 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Derived from this study: PubMed 31080025Akkan S, Corbacioglu SK, Aytar H, Emektar E, Dagar S, Cevik Y. Evaluating Effectiveness of Nasal Compression With Tranexamic Acid Compared With Simple Nasal Compression and Merocel Packing: A Randomized Controlled Trial. Ann Emerg Med. 2019 Jul;74(1):72-78. doi: 10.1016/j.annemergmed.2019.03.030. Epub 2019 May 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid, Normal saline and Merocel in people with Tranexamic Acid and Epistaxis, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of interventions to stop bleeding (time frame: First 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03360045, which also lists 1 linked publication.
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 7 Aug 2018.