Middle Ear DiseaseNCT06434636
The Effect of Tranexamic Acid in Endoscopic and Microscopic Ear Surgery Cases on Surgeon Satisfaction
A study testing Transamine 10% IV/IM Solution for Injection and %0.9 Saline in people with Middle Ear Disease, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
By using tranexamic acid, an antifibrinolytic drug, the aim is to prevent the restriction of the field of view of the surgical field due to bleeding in middle ear microscopic and endoscopic surgery operations in which controlled hypotension is applied, and therefore the prolongation of the surgical time, and to… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Middle Ear Disease
- What is being tested?
- Transamine 10% IV/IM Solution for Injection and %0.9 Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 6 Aug 2025
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals between the ages of 18-65
- Individuals with ASA I (no additional disease) or ASA II (mild systemic disease)
- Those who do not have a disease such as thrombophilia or bleeding diathesis will be included in the study
Who cannot join
- Patients with ASA III (those with uncontrolled chronic disease) or above
- Patients with cardiovascular disease, congestive heart failure, coronary artery disease, cerebrovascular insufficiency, renal or hepatic failure
- Patients with thrombophilia, bleeding diathesis, coagulation defects
- Pregnant patients
- Those with a history of any allergic reaction to tranexamic acid and its derivatives will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of The Use of Low Dose Tranexamic Acid on Surgeon Satisfaction, Side Effects and Complications in Endoscopic and Microscopic Ear Surgery Cases Which Are Used With Controlled Hypotension
By using tranexamic acid, an antifibrinolytic drug, the aim is to prevent the restriction of the field of view of the surgical field due to bleeding in middle ear microscopic and endoscopic surgery operations in which controlled hypotension is applied, and therefore the prolongation of the surgical time, and to increase surgeon satisfaction.
Read the detailed description
After obtaining approval from our university and the Turkish Ministry of Health's pharmaceutical and medical device agency and written consent from the patients, 100 patients who underwent middle ear surgery using controlled hypotension under general anesthesia will be included in the study.
The study will be conducted in a randomized controlled, double-blind manner. Patients between the ages of 18-65 and with American Society of Anesthesiologists (ASA) Scores I and II will be included in the study. Patients will be divided into two groups: Intervention (M) and Control (C). Just before the operation begins, 10 mg/kg tranexamic acid (TXA) will be administered to the intervention group in 100 mL of 0.9% physiological saline (SF) solution in 15 minutes. 100 mL of 0.9% SF solution will be sent to the control group in 15 minutes. At the end of the operation, the operator's quality of vision of the surgical field will be recorded by questioning the surgeon's satisfaction with the Boezaart Score and the Surgeon Satisfaction Score.
- Conditions
- Middle Ear Disease
- Being tested
- Transamine 10% IV/IM Solution for Injection, %0.9 Saline
- Keywords
- tranexamic acid, controlled hypotension, middle ear surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transamine 10% IV/IM Solution for InjectionDrug
Also called tranexamic acid
10 mg/kg tranexamic acid (Transamine 10% IV/IM Injectable Solution) will be placed into 100 cc physiological saline through the appropriate vascular access and injected within 15 minutes.
%0.9 SalineDrug
Also called Physiological Saline, %0.9 NaCl
100 cc %0.9 Normal Saline will be injected through the appropriate vascular access within 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (I) | Active comparator | Patients' vital values will be recorded before surgery.10 mg/kg tranexamic acid (Transamine 10% IV/IM Solution for Injection) is added into 100 cc serum through the appropriate vascular access and injected for 15 minutes.The amount of bleeding in the surgical field will be evaluated by the surgeon using the Boezaart Scale.Intraoperatively, hemodynamic changes such as bradycardia, tachycardia, arrhythmia and agents used such as vasopressors, antiarrhythmics and vagolytics will be recorded in the patient.Post-Operatively the surgeon's quality of vision will be questioned with the Surgeon Satisfaction Scale.Postoperative 0th, 12th, and 24th developments - the presence of vomiting and postoperative complaints will be questioned.The presence of bleeding or complications in the first 2 weeks after surgery will be questioned.The presence of thromboembolic events and other services will be questioned within 12 weeks after surgery. Receives: Drug: Transamine 10% IV/IM Solution for Injection |
| Control Group (C) | Placebo comparator | Preoperative vital values of the patients will be recorded.100 cc of physiological saline will be sent through the appropriate vascular access in 15 minutes.
The amount of bleeding in the surgical field will be evaluated by the surgeon using the Boezaart Scale. Intraoperatively, hemodynamic changes such as bradycardia, tachycardia, arrhythmia that develop in the patient, and agents such as vasopressors, antiarrhythmics, and vagolytics used will be recorded.
Postoperatively the surgeon's quality of vision will be questioned with the Surgeon Satisfaction Scale. The presence of nausea and vomiting and postoperative complaints will be questioned at the 0th, 12th, and 24th postoperative hours. The presence of surgical bleeding or complications that occur in the first 2 weeks of surgery will be questioned. The presence of thromboembolic events and other complications will be questioned within 12 weeks postoperatively. Receives: Drug: %0.9 Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boezaart et al grading scale
At the end of a surgery, the surgical field was graded in terms of bleeding by the surgeon using the scale used by Boezaart et al in 1995;
0 : No bleeding (cadaveric conditions).
- : Slight bleeding: no suctioning required.
- : Slight bleeding: occasional suctioning required.
- : Slight bleeding: frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.
- : Moderate bleeding: frequent suctioning required and bleeding threatens surgical field directly after suction is removed.
- : Severe bleeding: constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible.
Measured: 2-3 hours
Surgeon Satisfaction Score
At the and of surgery , surgeon's satisfaction with surgical field quality was also graded in a 5-item Likert scale, where 1 = poor and 5 = excellent
Measured: 2-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Dec 2024
- Primary completion5 May 2025
- Study completion6 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Middle Ear DiseaseStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be divided into two groups: Intervention (M) and Control (C). Just before the operation begins, 10 mg/kg tranexamic acid (TXA) will be administered to the intervention group in 100 mL of 0.9% physiological saline (SF) solution in 15 minutes. 100 mL of 0.9% SF solution will be sent to the control group in 15 minutes.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Talha Ersoy, TC Erciyes University
- Investigators
- Talha ERSOY, MD, Study chair, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434636
- Sponsor's protocol ID
- 2024/88
- Status last verified
- Aug 2025
- First submitted
- 19 May 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of The Use of Low Dose Tranexamic Acid on Surgeon Satisfaction, Side Effects and Complications in Endoscopic and Microscopic Ear Surgery Cases Which Are Used With Controlled Hypotension
- ClinicalTrials.gov ID
- NCT06434636
- Acronym / sponsor ID
- 2024/88
- Conditions
- Middle Ear Disease
- Keywords
- tranexamic acid, controlled hypotension, middle ear surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 6 Aug 2025 (actual)
- First posted
- 30 May 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.
By using tranexamic acid, an antifibrinolytic drug, the aim is to prevent the restriction of the field of view of the surgical field due to bleeding in middle ear microscopic and endoscopic surgery operations in which controlled hypotension is applied, and therefore the prolongation of the surgical time, and to increase surgeon satisfaction.
Detailed description
After obtaining approval from our university and the Turkish Ministry of Health's pharmaceutical and medical device agency and written consent from the patients, 100 patients who underwent middle ear surgery using controlled hypotension under general anesthesia will be included in the study.
The study will be conducted in a randomized controlled, double-blind manner. Patients between the ages of 18-65 and with American Society of Anesthesiologists (ASA) Scores I and II will be included in the study. Patients will be divided into two groups: Intervention (M) and Control (C). Just before the operation begins, 10 mg/kg tranexamic acid (TXA) will be administered to the intervention group in 100 mL of 0.9% physiological saline (SF) solution in 15 minutes. 100 mL of 0.9% SF solution will be sent to the control group in 15 minutes. At the end of the operation, the operator's quality of vision of the surgical field will be recorded by questioning the surgeon's satisfaction with the Boezaart Score and the Surgeon Satisfaction Score.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients will be divided into two groups: Intervention (M) and Control (C). Just before the operation begins, 10 mg/kg tranexamic acid (TXA) will be administered to the intervention group in 100 mL of 0.9% physiological saline (SF) solution in 15 minutes. 100 mL of 0.9% SF solution will be sent to the control group in 15 minutes.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (I) | Active comparator | Drug: Transamine 10% IV/IM Solution for InjectionPatients' vital values will be recorded before surgery.10 mg/kg tranexamic acid (Transamine 10% IV/IM Solution for Injection) is added into 100 cc serum through the appropriate vascular access and injected for 15 minutes.The amount of bleeding in the surgical field will be evaluated by the surgeon using the Boezaart Scale.Intraoperatively, hemodynamic changes such as bradycardia, tachycardia, arrhythmia and agents used such as vasopressors, antiarrhythmics and vagolytics will be recorded in the patient.Post-Operatively the surgeon's quality of vision will be questioned with the Surgeon Satisfaction Scale.Postoperative 0th, 12th, and 24th developments - the presence of vomiting and postoperative complaints will be questioned.The presence of bleeding or complications in the first 2 weeks after surgery will be questioned.The presence of thromboembolic events and other services will be questioned within 12 weeks after surgery. |
| Control Group (C) | Placebo comparator | Drug: %0.9 SalinePreoperative vital values of the patients will be recorded.100 cc of physiological saline will be sent through the appropriate vascular access in 15 minutes. The amount of bleeding in the surgical field will be evaluated by the surgeon using the Boezaart Scale. Intraoperatively, hemodynamic changes such as bradycardia, tachycardia, arrhythmia that develop in the patient, and agents such as vasopressors, antiarrhythmics, and vagolytics used will be recorded. Postoperatively the surgeon's quality of vision will be questioned with the Surgeon Satisfaction Scale. The presence of nausea and vomiting and postoperative complaints will be questioned at the 0th, 12th, and 24th postoperative hours. The presence of surgical bleeding or complications that occur in the first 2 weeks of surgery will be questioned. The presence of thromboembolic events and other complications will be questioned within 12 weeks postoperatively. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals between the ages of 18-65
- Individuals with ASA I (no additional disease) or ASA II (mild systemic disease)
- Those who do not have a disease such as thrombophilia or bleeding diathesis will be included in the study
Key exclusion criteria (5 listed)
- Patients with ASA III (those with uncontrolled chronic disease) or above
- Patients with cardiovascular disease, congestive heart failure, coronary artery disease, cerebrovascular insufficiency, renal or hepatic failure
- Patients with thrombophilia, bleeding diathesis, coagulation defects
- Pregnant patients
- Those with a history of any allergic reaction to tranexamic acid and its derivatives will be excluded from the study
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 |
|---|---|---|
| Transamine 10% IV/IM Solution for InjectionAlso: tranexamic acid10 mg/kg tranexamic acid (Transamine 10% IV/IM Injectable Solution) will be placed into 100 cc physiological saline through the appropriate vascular access and injected within 15 minutes. | Drug | Intervention Group (I) |
| %0.9 SalineAlso: Physiological Saline, %0.9 NaCl100 cc %0.9 Normal Saline will be injected through the appropriate vascular access within 15 minutes | Drug | Control Group (C) |
Primary outcome
Boezaart et al grading scale
Time frame: 2-3 hours
At the end of a surgery, the surgical field was graded in terms of bleeding by the surgeon using the scale used by Boezaart et al in 1995; 0 : No bleeding (cadaveric conditions). 1. : Slight bleeding: no suctioning required. 2. : Slight bleeding: occasional suctioning required. 3. : Slight bleeding: frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed. 4. : Moderate bleeding: frequent suctioning required and bleeding threatens surgical field directly after suction is removed. 5. : Severe bleeding: constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible.
Surgeon Satisfaction Score
Time frame: 2-3 hours
At the and of surgery , surgeon's satisfaction with surgical field quality was also graded in a 5-item Likert scale, where 1 = poor and 5 = excellent
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 8 Sep 2025.
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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.
Talha ERSOY, MD study chair
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transamine 10% IV/IM Solution for Injection and %0.9 Saline in people with Middle Ear Disease, run by TC Erciyes University 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 3 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 8 Sep 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 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.
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?
Boezaart et al grading scale (time frame: 2-3 hours). 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?
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 Sep 2025.