Bleeding NosePhase 3NCT04905901
Nebulized Tranexamic Acid in Sinus Surgery
A Phase 3 study testing Tranexamic acid in people with Bleeding Nose, run by Assiut University at 1 site in Egypt.
Trial summary
The results of several recent studies on endoscopic sinus surgery through topical administration of tranexamic acid are encouraging in terms of the efficacy of tranexamic acid for intraoperative bleeding and other pathological conditions.The purpose of this study is to analyze the efficacy of nebulized tranexamic acid… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bleeding Nose
- What is being tested?
- Tranexamic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 6 May 2021to 10 Jun 2026
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either sexes (age 18-65 years) of ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia
- normal accepted coagulation profile and hematocrit value ≥30
Who cannot join
- chronic renal failure
- liver cirrhosis
- bleeding disorders
- current anticoagulant therapy
- pregnancy or breastfeeding
- impaired color vision
Show all 10Show fewer
- severe vascular ischemia
- history of venous thrombosis, pulmonary embolism
- long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before surgery
- hemoglobin (HB) concentration <10 mg/dl _allergy to TXA.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Nebulized Tranexamic Acid Affect Operative Field in Sinus Surgery? A Double Blind Randomized Clinical Trial
The results of several recent studies on endoscopic sinus surgery through topical administration of tranexamic acid are encouraging in terms of the efficacy of tranexamic acid for intraoperative bleeding and other pathological conditions.The purpose of this study is to analyze the efficacy of nebulized tranexamic acid to improve the surgeon and patient experiences of sinus surgery and know the effective and safe dose of nebulized tranexamic acid.
Read the detailed description
A written informed consent will be taken from the patients.The study involved adults of either sexes (age 18-65 years) of ASA I-II who will be listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia, with normal accepted coagulation profile and hematocrit value ≥30 %. Excluded from the study patients with chronic renal failure, liver cirrhosis, bleeding disorders, current anticoagulant therapy, pregnancy or breastfeeding, impaired color vision, severe vascular ischemia, history of venous thrombosis, pulmonary embolism, long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before surgery, a hemoglobin (HB) concentration <10 mg/dl or allergy to TXA.
Randomization: A random number sequence created by an internet website (http://www. random.org) will be used for patients' allocation. The random number sequence was retained in closed opaque envelopes released the day of the surgery by an independent physician not involved in the study. Patients will be assigned randomly to three groups (30 subjects each); saline placebo (Group S) and two different doses of preemptive nebulized tranexamic acid (Group T1) and (Group T2).To keep blinding, Group S will receive 2 sessions of nebulization each by 5 ml saline. Group T1 will receive one nebulization session 500 mg tranexamic acid (5 ml) and another one by 5 ml saline. Group T2 will receive 2 nebulization sessions each by 500 mg tranexamic acid (each by 5 ml)
- Conditions
- Bleeding Nose
- Being tested
- Tranexamic acid, Saline placebo
- 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
Also called Cyclokapron
Tranexamic acid nebulization 15 minutes before sinus surgery
Saline placeboOther
Normal saline placebo nebulization 15 minutes before sinus surgery
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid 500 mg | Experimental | Nebulized tranexamic acid 500 mg 15 minutes before operation Receives: Drug: Tranexamic acid |
| Tranexamic acid 1gm | Experimental | Nebulized tranexamic acid 1 gm 15 minutes before operation Receives: Drug: Tranexamic acid |
| Saline placebo | Placebo comparator | Normal saline nebulization 15 minutes before operation Receives: Other: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Modena Bleeding Score (MBS) assessing surgical field
1= No bleeding, 2=Bleeding easily controlled by suctioning, washing or packing without any significant modification or slowing of surgical procedure, 3=Bleeding slowing surgical procedure, 4=Most of the maneuvers dedicated to bleeding control and 5=Bleeding that prevents every surgical procedure except those dedicated to bleeding control
Measured: After anesthesia induction to 60 minute
Secondary outcomes (4)
HR
Heart rate beat/min
Measured: Intraoperative duration
MBP
Mean blood pressure mmHg
Measured: Intraoperative duration
Anesthetic consumption
Extra doses of fentanyl and propofol and sevoflurane>2
Measured: Anesthesia duration
Postoperative complications
Recording any adverse effects to TXA e.g.nausea, vomiting and any visual disturbances
Measured: After operation to 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start6 May 2021
- Primary completion5 Jun 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding NoseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Makram Soliman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905901
- Sponsor's protocol ID
- 17300595
- Status last verified
- Jun 2026
- First submitted
- 17 May 2021
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Nebulized Tranexamic Acid Affect Operative Field in Sinus Surgery? A Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04905901
- Acronym / sponsor ID
- 17300595
- Conditions
- Bleeding Nose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 28 May 2021 (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.
The results of several recent studies on endoscopic sinus surgery through topical administration of tranexamic acid are encouraging in terms of the efficacy of tranexamic acid for intraoperative bleeding and other pathological conditions.The purpose of this study is to analyze the efficacy of nebulized tranexamic acid to improve the surgeon and patient experiences of sinus surgery and know the effective and safe dose of nebulized tranexamic acid.
Detailed description
A written informed consent will be taken from the patients.The study involved adults of either sexes (age 18-65 years) of ASA I-II who will be listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia, with normal accepted coagulation profile and hematocrit value ≥30 %. Excluded from the study patients with chronic renal failure, liver cirrhosis, bleeding disorders, current anticoagulant therapy, pregnancy or breastfeeding, impaired color vision, severe vascular ischemia, history of venous thrombosis, pulmonary embolism, long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before surgery, a hemoglobin (HB) concentration <10 mg/dl or allergy to TXA.
Randomization: A random number sequence created by an internet website (http://www. random.org) will be used for patients' allocation. The random number sequence was retained in closed opaque envelopes released the day of the surgery by an independent physician not involved in the study. Patients will be assigned randomly to three groups (30 subjects each); saline placebo (Group S) and two different doses of preemptive nebulized tranexamic acid (Group T1) and (Group T2).To keep blinding, Group S will receive 2 sessions of nebulization each by 5 ml saline. Group T1 will receive one nebulization session 500 mg tranexamic acid (5 ml) and another one by 5 ml saline. Group T2 will receive 2 nebulization sessions each by 500 mg tranexamic acid (each by 5 ml)
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 500 mg | Experimental | Drug: Tranexamic acidNebulized tranexamic acid 500 mg 15 minutes before operation |
| Tranexamic acid 1gm | Experimental | Drug: Tranexamic acidNebulized tranexamic acid 1 gm 15 minutes before operation |
| Saline placebo | Placebo comparator | Other: Saline placeboNormal saline nebulization 15 minutes before operation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Either sexes (age 18-65 years) of ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia
- normal accepted coagulation profile and hematocrit value ≥30
Key exclusion criteria (10 listed)
- chronic renal failure
- liver cirrhosis
- bleeding disorders
- current anticoagulant therapy
- pregnancy or breastfeeding
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 acidAlso: CyclokapronTranexamic acid nebulization 15 minutes before sinus surgery | Drug | Tranexamic acid 1gm, Tranexamic acid 500 mg |
| Saline placeboNormal saline placebo nebulization 15 minutes before sinus surgery | Other | Saline placebo |
Primary outcome
the Modena Bleeding Score (MBS) assessing surgical field
Time frame: After anesthesia induction to 60 minute
1= No bleeding, 2=Bleeding easily controlled by suctioning, washing or packing without any significant modification or slowing of surgical procedure, 3=Bleeding slowing surgical procedure, 4=Most of the maneuvers dedicated to bleeding control and 5=Bleeding that prevents every surgical procedure except those dedicated to bleeding control
4 secondary outcomes
HR
Time frame: Intraoperative duration
MBP
Time frame: Intraoperative duration
Anesthetic consumption
Time frame: Anesthesia duration
Postoperative complications
Time frame: After operation to 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 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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 3 study testing Tranexamic acid in people with Bleeding Nose, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 10 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 16 Jun 2026. 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 Egypt. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
the Modena Bleeding Score (MBS) assessing surgical field (time frame: After anesthesia induction to 60 minute). 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 16 Jun 2026.