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Blood Loss, SurgicalEarly Phase 1NCT06725732

Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score

A Early Phase 1 study testing Tranexamic Acid (TXA) and Tranexamic Acid in people with Blood Loss, Surgical, run by Assiut University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of this study is to investigate the effect of preoperative administration of intravenous or nebulized tranexamic acid on surgical field, blood loss, anesthetic consumption and hemodynamics of patients undergoing FESS. Primary outcome Modena Bleeding Score (MBS) assessing surgical field Secondary outcome 1. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Blood Loss, Surgical
What is being tested?
Tranexamic Acid (TXA) and Tranexamic Acid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteEgypt
Study dates
29 Jan 2025to 1 Jan 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Either sex
  • age 18-65 years
  • 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 11Show 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.
  • BMI > 35 kg/ m2

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Asmaa Shabaan Zanaty, Doctor contact

+201029505921

asmaa10557@gmail.com

Egypt1 site, 1 recruiting

  • Main building, Assiut University Hospitals

    Asyut

    Asmaa Shabaan, +201029505921, asmaa10557@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score. A Randomized Double Blinded Controlled Trial.

The aim of this study is to investigate the effect of preoperative administration of intravenous or nebulized tranexamic acid on surgical field, blood loss, anesthetic consumption and hemodynamics of patients undergoing FESS.

Primary outcome Modena Bleeding Score (MBS) assessing surgical field Secondary outcome

  1. Patient hemodynamics.
  2. Anesthetic consumption, Extra doses of fentanyl and propofol and sevoflurane>2
  3. Postoperative complications: including any adverse effects to TXA e.g.nausea, vomiting, any visual disturbances, fits, and any thrombotic manifestation.
Read the detailed description

Functional endoscopic sinus surgery (FESS) is the current standard treatment for a variety of conditions affecting the nasal cavity and the paranasal sinuses, such as chronic rhinosinusitis, benign and malignant tumors or cerebrospinal fluid leaks .Being mostly a one-handed technique, FESS does not allow simultaneous use of operative instruments and blood suction, thus endonasal bleeding control represents a challenging issue for the operating surgeon. Such narrow and highly vascularized cavities like the nasal fossae and paranasal spaces can be entirely filled with blood within few seconds, especially if the mucosa is severely inflamed as a consequence of rhinosinusitis. Bleeding is possibly the most relevant factor that could impair the quality of the surgical field during endoscopic procedures. It has been proven that uncontrolled bleeding during endoscopic sinus surgical procedures determines poor visualization of the anatomical landmarks, prolongs surgical time and carries a higher rate of complications .Several techniques to control intraoperative bleeding and improve surgical view during sinus surgery (e.g. topical vasoconstrictors, total intravenous anesthesia, controlled hypotension) have been described and analyzed to determine their efficacy .These types of studies, however, are complex and prone to bias, partially because standardized and validated methods of quantifying bleeding or grading the surgical field in endoscopic view are lacking.

Tranexamic acid functions as the competitive antagonist at the lysine site on plasminogen . During all surgical procedures, the tissue plasminogen activator is released due to tissue damage during surgery, which can convert tissue plasminogen to plasmin, promote fibrinolysis and activate the fibrinolytic system. Thus, tranexamic acid functions as an anti-fibrinolytic agent by inhibiting the tissue plasminogen activator. It can be applied topically or systemically with this mechanism in the coagulation cascade to reduce intraoperative bleeding .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 and compare it with intravenous tranexamic acid to improve the surgeon and patient experiences of sinus surgery.

Being tested
Tranexamic Acid (TXA), Tranexamic Acid
Medical subject headings
Blood Loss, Surgical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic Acid (TXA)Drug

    To see if nebulised TXA is better to control blood loss in functional Endoscopic sinus surgery

  • Tranexamic AcidDrug

    To see if intravenous TXA is better to control blood loss in functional Endoscopic sinus surgery

Study groups in NCT06725732
Study groupRoleWhat they receive
IntravenousExperimentalNot described
Receives: Drug: Tranexamic Acid
NebulizedExperimentalNot described
Receives: Drug: Tranexamic Acid (TXA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modena Bleeding Score- assessing surgical field

    • No bleeding ->1.
    • Bleeding easily controlled by suctioning, washing, or packing without any significant modification or slowing of surgical procedure->2.
    • Bleeding slowing surgical procedure->3.
    • Most of the maneuvers dedicated to bleeding control ->4.
    • Bleeding that prevents every surgical procedure except those dedicated to bleeding control->5.

    Measured: Baseline

Secondary outcomes (12)

  1. Measuring patient's Blood Pressure-> mmhg (unit of measure)

    Measured: Baseline

  2. Measuring patient's Respiratory Rate-> breath per minute(unit of measure)

    Measured: Baseline

  3. Measuring patient's Temperature-> Celsius(unit of measure)

    Measured: Baseline

  4. Measuring patient's Pulse->Beat per minute(unit of measure)

    Measured: Baseline

  5. Measuring End-tidal Co2 by Capnogram

    Unit of measure-> mmhg

    Measured: Baseline

  6. Measuring O2 saturation by the pulse-oximeter

    Measured: Baseline

  7. Measuring amount of intraoperative bleeding through blood volume in suction jar

    Measured: Baseline

  8. Measuring the amount of intraoperative bleeding by counting gauze used in the operation.

    Measured: Baseline

  9. 2. Anesthetic consumption, Extra doses of fentanyl and propofol and sevoflurane>2

    Measured: Baseline

  10. Presence or absence of nausea as a Postoperative complication

    Measured: Baseline

  11. Presence or absence of vomiting as a Postoperative complication

    Measured: Baseline

  12. Presence or absence of any form of visual disturbance as a Postoperative complication

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2024
  2. Study start29 Jan 2025 (estimated)
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06725732
Sponsor's protocol ID
IV & Nebulized TXA in FESS
Status last verified
Nov 2024
First submitted
26 Nov 2024
Last updated
29 Jan 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kang H, Hwang SH. Does topical application of tranexamic acid reduce intraoperative bleeding in sinus surgery during general anesthesia? Braz J Otorhinolaryngol. 2020 Jan-Feb;86(1):111-118. doi: 10.1016/j.bjorl.2019.08.006. Epub 2019 Oct 3.

    PubMed 31653606

  • Khosla AJ, Pernas FG, Maeso PA. Meta-analysis and literature review of techniques to achieve hemostasis in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Jun;3(6):482-7. doi: 10.1002/alr.21126. Epub 2012 Dec 16.

    PubMed 23255493

  • Kim DH, Kim S, Kang H, Jin HJ, Hwang SH. Efficacy of tranexamic acid on operative bleeding in endoscopic sinus surgery: A meta-analysis and systematic review. Laryngoscope. 2019 Apr;129(4):800-807. doi: 10.1002/lary.27766. Epub 2018 Dec 28.

    PubMed 30593688

  • Alicandri-Ciufelli M, Pingani L, Mariano D, Anschuetz L, Molinari G, Marchioni D, Bonali M, Galeazzi GM, Presutti L. Rating surgical field quality in endoscopic ear surgery: proposal and validation of the "Modena Bleeding Score". Eur Arch Otorhinolaryngol. 2019 Feb;276(2):383-388. doi: 10.1007/s00405-018-05268-6. Epub 2019 Jan 2.

    PubMed 30604058

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Tranexamic Acid (TXA) and Tranexamic Acid in people with Blood Loss, Surgical, 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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 29 Jan 2025. 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. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Asmaa Shabaan Zanaty, Doctor (+201029505921, asmaa10557@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modena Bleeding Score- assessing surgical field (time frame: Baseline). 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 NCT06725732, which also lists 4 linked publications.

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 29 Jan 2025.

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