AnesthesiaPhase 4NCT05686005
Tranexamic Acid in Functional Endoscopic Sinus Surgery
A Phase 4 study testing Oral tranexamic acid and Intravenous tranexamic acid in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of the study is to compare the effect of oral tranexamic acid vs. intravenous in decreasing bleeding and improving the field during FESS. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Oral tranexamic acid and Intravenous tranexamic acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Dec 2022to 30 Apr 2023
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists grade I or II.
- Sex: Both sexes.
- Age between 18 and 40 years.
- Patients scheduled for FESS under general anesthesia.
Who cannot join
- Declining to give written informed consent.
- History of allergy to the medications used in the study.
- History of venous or arterial thrombosis.
- history of cardiovascular diseases including AF, IHD, or hypertension.
- History of chest problems including pulmonary embolism, bronchial asthma and COPD.
- History of cerebrovascular stroke.
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- History of drug or alcohol abuse.
- Taking opioids or sedative medications.
- Hepatic or renal failure.
- Bleeding disorders, antiplatelets (aspirin, clopidogrel) or anticoagulant (warfarin).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Oral Versus Intravenous Tranexamic Acid in Functional Endoscopic Sinus Surgery. A Prospective, Randomized, Double-blind Controlled Trial.
The purpose of the study is to compare the effect of oral tranexamic acid vs. intravenous in decreasing bleeding and improving the field during FESS.
Read the detailed description
The use of tranexamic acid during Intraoperative bleeding in functional endoscopic sinus surgery (FESS) improves the outcome. Bleeding is one of the most devastating complications during fess. Tranexamic acid is used in open heart surgery to improve the surgical field.
Using oral vs. intravenous forms of the drug will add to our knowledge and improve outcomes.
- Conditions
- Anesthesia
- Being tested
- Oral tranexamic acid, Intravenous tranexamic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral tranexamic acidDrug
4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.
Intravenous tranexamic acidDrug
15mg/kg of tranexamic acid in a 20ml syringe slowly intravenous during induction.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| Oral tranexamic | Active comparator | The participants will receive 4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward. Receives: Drug: Oral tranexamic acid |
| Intravenous tranexamic | Active comparator | The participants will receive 15 mg/kg in a 20ml syringe slowly tranexamic acid during induction. Receives: Drug: Intravenous tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative field bleeding
The Wormald grading system for bleeding during endoscopic sinus surgery (0= no bleeding and 10= severe bleeding with sphenoid fills < 10 seconds)
Measured: At 30 minutes after surgery start
Secondary outcomes (2)
Incidence of the common adverse effects
Postoperative nasal bleeding, nausea, and vomiting.
Measured: At 24 hours
Post operative D-dimer
Measured: At 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start3 Dec 2022
- Primary completion29 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Samir Abdelsalam, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686005
- Sponsor's protocol ID
- FMASU R 237/ 2022
- Status last verified
- May 2023
- First submitted
- 6 Jan 2023
- Last updated
- 3 May 2023
- 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Oral Versus Intravenous Tranexamic Acid in Functional Endoscopic Sinus Surgery. A Prospective, Randomized, Double-blind Controlled Trial.
- ClinicalTrials.gov ID
- NCT05686005
- Acronym / sponsor ID
- FMASU R 237/ 2022
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 Dec 2022 (actual)
- Primary completion
- 29 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 17 Jan 2023 (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 purpose of the study is to compare the effect of oral tranexamic acid vs. intravenous in decreasing bleeding and improving the field during FESS.
Detailed description
The use of tranexamic acid during Intraoperative bleeding in functional endoscopic sinus surgery (FESS) improves the outcome. Bleeding is one of the most devastating complications during fess. Tranexamic acid is used in open heart surgery to improve the surgical field.
Using oral vs. intravenous forms of the drug will add to our knowledge and improve outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| Oral tranexamic | Active comparator | Drug: Oral tranexamic acidThe participants will receive 4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward. |
| Intravenous tranexamic | Active comparator | Drug: Intravenous tranexamic acidThe participants will receive 15 mg/kg in a 20ml syringe slowly tranexamic acid during induction. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists grade I or II.
- Sex: Both sexes.
- Age between 18 and 40 years.
- Patients scheduled for FESS under general anesthesia.
Key exclusion criteria (10 listed)
- Declining to give written informed consent.
- History of allergy to the medications used in the study.
- History of venous or arterial thrombosis.
- history of cardiovascular diseases including AF, IHD, or hypertension.
- History of chest problems including pulmonary embolism, bronchial asthma and COPD.
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 |
|---|---|---|
| Oral tranexamic acid4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward. | Drug | Oral tranexamic |
| Intravenous tranexamic acid15mg/kg of tranexamic acid in a 20ml syringe slowly intravenous during induction. | Drug | Intravenous tranexamic |
Primary outcome
Intraoperative field bleeding
Time frame: At 30 minutes after surgery start
The Wormald grading system for bleeding during endoscopic sinus surgery (0= no bleeding and 10= severe bleeding with sphenoid fills < 10 seconds)
2 secondary outcomes
Incidence of the common adverse effects
Time frame: At 24 hours
Post operative D-dimer
Time frame: At 24 hours
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 3 May 2023.
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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 Oral tranexamic acid and Intravenous tranexamic acid in people with Anesthesia, 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 4 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 3 May 2023. 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?
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?
Intraoperative field bleeding (time frame: At 30 minutes after surgery start). 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 3 May 2023.