Chronic Sinus DiseasePhase 3NCT03965767
Does The Combined Use Of Local And Intravenous Tranexamic Acid Offer Better Surgical Field Quality During Functional Endoscopic Sinus Surgery? A Placebo-Controlled Clinical Trial
A Phase 3 study testing Tranexamic Acid in people with Chronic Sinus Disease and Nasal Polyps, run by Ain Shams University at 1 site in Egypt.
Trial summary
Functional Endoscopic Sinus surgery (FESS) is a surgery done for chronic rhinosinusitis after failure of medical treatment. Intraoperative bleeding poses a challenge to both the surgeon and anaesthetist. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Sinus Disease, Nasal Polyps
- What is being tested?
- Tranexamic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2019to 1 Sep 2019
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients underwent endoscopic sinus surgery
Who cannot join
- patients with uncontrolled hypertension or coronary artery disease, anaemia, end stage renal failure, liver cirrhosis, patients with coagulopathy or receiving drugs influencing blood coagulation, cerebrovascular thrombosis or history of thrombotic events, pregnancy, known sensitivity to any of the study drug and patients' refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Ain Shams University
Cairo
ossama mady, MD, 01117341201 ext. 202, omady84@gmail.com
About this study
Functional Endoscopic Sinus surgery (FESS) is a surgery done for chronic rhinosinusitis after failure of medical treatment. Intraoperative bleeding poses a challenge to both the surgeon and anaesthetist. Although blood loss is not massive during FESS, bleeding may obscure the surgical field prolonging the time of surgery or even leading to incompletion of the surgery.
Different methods have been used to improve the surgical field but none without side effects. The use of diathermy carries the risk of local tissue damage with the risk of subsequent bleeding. Local vasoconstrictors carry the risk of systemic absorption. Induced hypotension may not be suitable for all patients; besides, this may necessitates the use of more anaestheic drugs with their associated side effects. In addition, none of theses methods have provided ideal surgical field for the surgeon.1-3 Tranexamic acid, an antifibrinolytic agent, has been used to decrease surgical field bleeding in different surgeries showing effectiveness in its topical, oral and intravenous use.4-6 The aim of this study is to evaluate the effectiveness of local, intravenous and combined use of tranexamic acid in improving the surgical field quality during functional endoscopic sinus surgery.
Read the detailed description
After obtaining local ethical committee approval and written informed consent from the patients, 90 adult patients of both sex, aged between 18 and 50 years, ASA I-II, scheduled for elective functional endoscopic sinus surgery in Ain Shams University hospitals will be enrolled in this randomized, controlled prospective double blinded study.
Exclusion criteria included; patients with uncontrolled hypertension or coronary artery disease, anaemia, end stage renal failure, liver cirrhosis, patients with coagulopathy or receiving drugs influencing blood coagulation, cerebrovascular thrombosis or history of thrombotic events, pregnancy, known sensitivity to any of the study drug and patients' refusal to participate in the study.
The surgeon will assess the degree of sinus involvement in each patient using the Lund-Mackay scoring system. All the patients will be instructed to take prednisone 1 mg. kg-1 5 days before surgery to reduce inflammation.
After applying basic monitors, all patients will be premedicated with midazolam 0.05 mg.kg -1 IV, ranitidine 50 mg IV and dexamethasone 10 mg IV, 15 min. prior to surgery.
In the operating room and after 5 min preoxygenation, general anesthesia will be conducted using the same protocol for all patients: fentanyl 1 μg.Kg-1, propofol 2-2.5 mg.kg -1 and atracurium 0.5 mg. Kg-1 to facilitate endotracheal intubation.
Anaesthesia will be maintained using isoflurane 1 -1.5% in oxygen and air mixture 1:1 and atracurium 0.1 mg. Kg-1 every 30 mim. Positive pressure ventilation was set to maintain normocapnia. Fentanyl bolus of 0.5 μg.Kg-1 to maintain MAP (60-70 mmHg), without exceeding a total dose of 5 μg.Kg-1 for fast tracking and early extubation. Total dose of fentanyl will be recorded.
A throat pack soaked with saline will be inserted in all patients to prevent blood from reaching the gastrointestinal track. The surgeon will insert nasal pack (epinephrine 1/2000 soaked pack), Afterwards, he will inject 2 ml of epinephrine 1:100000 into the middle turbinate and the junction of the middle turbinate to the lateral nasal wall. All patients will be placed in the same position.
Patients will then be randomly and evenly assigned to one of the four groups, 30 patients each.
Group I: patients will receive an intravenous dose of 15 mg.kg-1 of tranexamic acid in a 10 ml syringe. The irrigation fluid will be 400 ml of normal saline.
Group II: patients will receive intravenous dose of 10 ml normal saline in 10 ml syringe. Irrigation fluid will be 400 ml of normal saline with 2 g of tranexamic acid added to it. If more irrigation is needed, normal saline will be used.
Group III: patients will receive an intravenous dose of 15 mg.kg-1 of tranexamic acid in a 10 ml syringe. Irrigation fluid will be 400 ml of normal saline with 2 g of tranexamic acid added to it. If more irrigation is needed, normal saline will be used.
Group IV (control): patients will receive intravenous dose of 10 ml normal saline in 10 ml syringe. The irrigation fluid will be 400 ml of normal saline.
Randomization was done using computer generated list. A pharmacist will prepare the drugs, as well as the irrigation fluid, which will only have the patient's number on them. In this way, the anaesthetist and the surgeon will be blinded to the study groups. The same surgeon performed all the operations.
In all groups, if bleeding was uncontrollable and affecting the surgical field, loading dose of esmolol 500 μg.Kg-1 will be started, followed by infusion of 100-300 mg.Kg-1.min-1. The use and total dose of esmolol will be reported.
MAP and HR will recorded before induction of anaesthesia (baseline), immediately after induction, and every 15 mim till completion of surgery.
Beside the maintenance fluid infusion, intraoperative blood loss will be compensated with crystalloids in a ratio of 1:3.
Prothrombin time (PT), partial thromboplastin time (PTT) and complete blood count (CBC) will be measured before surgery and 6 hours after surgery.
The surgeon will be asked to estimate the surgical field on a 5-point Boezaart scale immediately at the end of the surgery (table 1).
Table 1: Surgical field quality based on Boezaart scale. 7 Grade Assessment 0 No bleeding.
- Slight bleeding, no suction of blood required.
- Slight bleeding, occasional suction required.
- Slight bleeding, frequent suction required. Bleeding threatens surgical field few seconds after suction is removed.
- Moderate bleeding, frequent suction required. Bleeding threatens surgical field directly after suction is removed.
- Severe bleeding, constant suction required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible
The incidence of postoperative complications including; epistaxis, nausea, vomiting and pain (using VAS) will be evaluated in the PACU.
- Conditions
- Chronic Sinus Disease, Nasal Polyps
- Being tested
- Tranexamic Acid
- Keywords
- endoscopic sinus surgery- tranexamic acid
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
comparison of effect of tranexamic acid on control of bleeding when used locally in the nose or systemic use
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | Not described Receives: Drug: Tranexamic Acid |
| local group | Active comparator | Not described Receives: Drug: Tranexamic Acid |
| systemic group | Active comparator | Not described Receives: Drug: Tranexamic Acid |
| combined local and systemic | Active comparator | Not described Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding during surgery
surgeon satisfaction
Measured: time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start25 Apr 2019
- Primary completion25 Aug 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Sinus DiseaseStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ossama Mustafa Mady, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965767
- Sponsor's protocol ID
- FMASU R 27-2019
- Status last verified
- May 2019
- First submitted
- 24 May 2019
- Last updated
- 29 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does The Combined Use Of Local And Intravenous Tranexamic Acid Offer Better Surgical Field Quality During Functional Endoscopic Sinus Surgery? A Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03965767
- Acronym / sponsor ID
- FMASU R 27-2019
- Conditions
- Chronic Sinus Disease, Nasal Polyps
- Keywords
- endoscopic sinus surgery- tranexamic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 25 Aug 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 29 May 2019 (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.
Functional Endoscopic Sinus surgery (FESS) is a surgery done for chronic rhinosinusitis after failure of medical treatment. Intraoperative bleeding poses a challenge to both the surgeon and anaesthetist. Although blood loss is not massive during FESS, bleeding may obscure the surgical field prolonging the time of surgery or even leading to incompletion of the surgery.
Different methods have been used to improve the surgical field but none without side effects. The use of diathermy carries the risk of local tissue damage with the risk of subsequent bleeding. Local vasoconstrictors carry the risk of systemic absorption. Induced hypotension may not be suitable for all patients; besides, this may necessitates the use of more anaestheic drugs with their associated side effects. In addition, none of theses methods have provided ideal surgical field for the surgeon.1-3 Tranexamic acid, an antifibrinolytic agent, has been used to decrease surgical field bleeding in different surgeries showing effectiveness in its topical, oral and intravenous use.4-6 The aim of this study is to evaluate the effectiveness of local, intravenous and combined use of tranexamic acid in improving the surgical field quality during functional endoscopic sinus surgery.
Detailed description
After obtaining local ethical committee approval and written informed consent from the patients, 90 adult patients of both sex, aged between 18 and 50 years, ASA I-II, scheduled for elective functional endoscopic sinus surgery in Ain Shams University hospitals will be enrolled in this randomized, controlled prospective double blinded study.
Exclusion criteria included; patients with uncontrolled hypertension or coronary artery disease, anaemia, end stage renal failure, liver cirrhosis, patients with coagulopathy or receiving drugs influencing blood coagulation, cerebrovascular thrombosis or history of thrombotic events, pregnancy, known sensitivity to any of the study drug and patients' refusal to participate in the study.
The surgeon will assess the degree of sinus involvement in each patient using the Lund-Mackay scoring system. All the patients will be instructed to take prednisone 1 mg. kg-1 5 days before surgery to reduce inflammation.
After applying basic monitors, all patients will be premedicated with midazolam 0.05 mg.kg -1 IV, ranitidine 50 mg IV and dexamethasone 10 mg IV, 15 min. prior to surgery.
In the operating room and after 5 min preoxygenation, general anesthesia will be conducted using the same protocol for all patients: fentanyl 1 μg.Kg-1, propofol 2-2.5 mg.kg -1 and atracurium 0.5 mg. Kg-1 to facilitate endotracheal intubation.
Anaesthesia will be maintained using isoflurane 1 -1.5% in oxygen and air mixture 1:1 and atracurium 0.1 mg. Kg-1 every 30 mim. Positive pressure ventilation was set to maintain normocapnia. Fentanyl bolus of 0.5 μg.Kg-1 to maintain MAP (60-70 mmHg), without exceeding a total dose of 5 μg.Kg-1 for fast tracking and early extubation. Total dose of fentanyl will be recorded.
A throat pack soaked with saline will be inserted in all patients to prevent blood from reaching the gastrointestinal track. The surgeon will insert nasal pack (epinephrine 1/2000 soaked pack), Afterwards, he will inject 2 ml of epinephrine 1:100000 into the middle turbinate and the junction of the middle turbinate to the lateral nasal wall. All patients will be placed in the same position.
Patients will then be randomly and evenly assigned to one of the four groups, 30 patients each.
Group I: patients will receive an intravenous dose of 15 mg.kg-1 of tranexamic acid in a 10 ml syringe. The irrigation fluid will be 400 ml of normal saline.
Group II: patients will receive intravenous dose of 10 ml normal saline in 10 ml syringe. Irrigation fluid will be 400 ml of normal saline with 2 g of tranexamic acid added to it. If more irrigation is needed, normal saline will be used.
Group III: patients will receive an intravenous dose of 15 mg.kg-1 of tranexamic acid in a 10 ml syringe. Irrigation fluid will be 400 ml of normal saline with 2 g of tranexamic acid added to it. If more irrigation is needed, normal saline will be used.
Group IV (control): patients will receive intravenous dose of 10 ml normal saline in 10 ml syringe. The irrigation fluid will be 400 ml of normal saline.
Randomization was done using computer generated list. A pharmacist will prepare the drugs, as well as the irrigation fluid, which will only have the patient's number on them. In this way, the anaesthetist and the surgeon will be blinded to the study groups. The same surgeon performed all the operations.
In all groups, if bleeding was uncontrollable and affecting the surgical field, loading dose of esmolol 500 μg.Kg-1 will be started, followed by infusion of 100-300 mg.Kg-1.min-1. The use and total dose of esmolol will be reported.
MAP and HR will recorded before induction of anaesthesia (baseline), immediately after induction, and every 15 mim till completion of surgery.
Beside the maintenance fluid infusion, intraoperative blood loss will be compensated with crystalloids in a ratio of 1:3.
Prothrombin time (PT), partial thromboplastin time (PTT) and complete blood count (CBC) will be measured before surgery and 6 hours after surgery.
The surgeon will be asked to estimate the surgical field on a 5-point Boezaart scale immediately at the end of the surgery (table 1).
Table 1: Surgical field quality based on Boezaart scale. 7 Grade Assessment 0 No bleeding.
- Slight bleeding, no suction of blood required.
- Slight bleeding, occasional suction required.
- Slight bleeding, frequent suction required. Bleeding threatens surgical field few seconds after suction is removed.
- Moderate bleeding, frequent suction required. Bleeding threatens surgical field directly after suction is removed.
- Severe bleeding, constant suction required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible
The incidence of postoperative complications including; epistaxis, nausea, vomiting and pain (using VAS) will be evaluated in the PACU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Drug: Tranexamic Acid |
| local group | Active comparator | Drug: Tranexamic Acid |
| systemic group | Active comparator | Drug: Tranexamic Acid |
| combined local and systemic | Active comparator | Drug: Tranexamic Acid |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients underwent endoscopic sinus surgery
Key exclusion criteria (1 listed)
- patients with uncontrolled hypertension or coronary artery disease, anaemia, end stage renal failure, liver cirrhosis, patients with coagulopathy or receiving drugs influencing blood coagulation, cerebrovascular thrombosis or history of thrombotic events, pregnancy, known sensitivity to any of the study drug and patients' refusal to participate in 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 |
|---|---|---|
| Tranexamic Acidcomparison of effect of tranexamic acid on control of bleeding when used locally in the nose or systemic use | Drug | combined local and systemic, control, local group, systemic group |
Primary outcome
bleeding during surgery
Time frame: time of surgery
surgeon satisfaction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
Related trials for Chronic Sinus Disease
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RecruitingObservational study
Rhinosinusitis Italian Network: the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis
Chronic Rhinosinusitis
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.
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 Chronic Sinus Disease and Nasal Polyps, run by Ain Shams 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 1 inclusion and 1 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 29 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Research ethics comittee (26857539 ext. 202, fathytash@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding during surgery (time frame: time of surgery). 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 29 May 2019.