Pain, PostoperativePhase 3NCT04724772
Use of Tranexamic Acid in Blepharoplasties
A Phase 3 study testing Tranexamic acid injection in people with Pain, Postoperative and Bruising, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this investigation is to assess whether or not there is a significant difference in the presence and/or degree of post-operative ecchymosis, pain, and edema between groups of patients undergoing upper lid blepharoplasty with traditional local anesthetic (LA) and those who receive tranexamic acid (TXA) in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Bruising
- What is being tested?
- Tranexamic acid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2020to 20 Sep 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- any adult patient who is undergoing upper lid blepharoplasty with author Douglas Sidle, MD and who is older than 18 years of age, fluent in English, not on any anticoagulant or antiplatelet medication (e.g. aspirin, clopidogrel, etc.), not diagnosed with a coagulation disorder, not pregnant, not undergoing a simultaneous procedure, and not a Feinberg School of Medicine (FSM) student or Northwestern Memorial (NM) employee.
Who cannot join
- less than 18 years of age, not fluent in English, taking anticoagulant or antiplatelet, has coagulation disorder, pregnant, simultaneous procedure, FSM or NM student/employee
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Comparison of Clinical Outcomes Following Upper Lid Blepharoplasty With and Without Tranexamic Acid as an Additive to Traditional Local Anesthetic.
The goal of this investigation is to assess whether or not there is a significant difference in the presence and/or degree of post-operative ecchymosis, pain, and edema between groups of patients undergoing upper lid blepharoplasty with traditional local anesthetic (LA) and those who receive tranexamic acid (TXA) in addition to traditional LA.
Read the detailed description
Blood clot formation involves a cascade of reactions that results in the production of thrombin, which converts fibrinogen into fibrin. In turn, fibrin aggregates and forms a clot. Hemostasis depends on a balance between this clotting cascade and the processes that break down clots, particularly the conversion of plasminogen to plasmin and plasmin's subsequent degradation of fibrin polymers. Tranexamic acid (TXA) is an agent, first patented in 1957, that competitively inhibits plasmin generation and activity.
As a result, TXA promotes clotting and, therein, hemostasis, making it useful for controlling surgical bleeding. (See figure below.) Indeed, a 2012 meta-analysis demonstrated that administering TXA intra- or perioperatively reduces the probability of receiving a blood transfusion by one-third.
Additionally, large trials have shown that TXA does not increase the risk of thromboembolic events in patients. One study noted that there was a slightly increased incidence of seizures in patients who received TXA, though this was limited to patients who underwent open-heart surgery, which is, itself, an independent risk factor for seizures. Another study halved the dose of TXA administered to its participants, but this did not reduce seizure risk amongst the participants. Thus, the data on this adverse effect remains inconclusive, and surgeons continue using TXA for its hemostatic effects, especially in cardiac and orthopedic surgeries. Given that facial plastic surgery does not incur the same sort of blood loss as cardiac or orthopedic surgery, efforts to describe TXA use in this field have focused on its established anti-inflammatory properties in addition to hemostasis. There are reports of TXA use in rhinoplasties, face lifts, and blepharoplasties; however, such reports are scarce, with randomized, double-blinded, controlled clinical trials even more so. Only one study has examined TXA use in blepharoplasties. In that study, 34 patients were randomized to receive an injection of lidocaine mixed with either TXA or saline. The authors did not find any significant difference in post-operative parameters including size of periocular ecchymoses and patient-reported pain level. Since the only randomized controlled trial investigating TXA use in blepharoplasty involved 34 participants, the investigators aim to add to the body of knowledge on this matter.
Furthermore, the investigator's study will be structured differently from that of Sagiv et al. Firstly, the patients will serve as their own controls, since we will inject one eyelid with a solution containing TXA and another with a placebo solution. This will help reduce bias between study groups that may have existed in Sagiv et al's trial. Secondly, the investigators will follow the patients for 3 months after the procedure, which is eleven weeks longer than the duration of follow-up amongst participants in Sagiv et al's trial. This will give the investigators an even better sense of TXA's impact on patients' post-operative courses. In summary, the investigators wish to characterize TXA's hemostatic and anti-inflammatory effects in patients who undergo blepharoplasty. Since there is currently only one publication that accomplishes this, the investigators' objective is to expand knowledge in this area so that surgeons performing facial plastic procedures can optimize patients' recovery and outcomes.
- Conditions
- Pain, Postoperative, Bruising
- Being tested
- Tranexamic acid injection
- Medical subject headings
- Pain, Postoperative, Contusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
Injection of tranexamic acid preoperatively
| Study group | Role | What they receive |
|---|---|---|
| Blepharoplasty patient | Experimental | Patient receives LA in one eye and LA with TXA in the other eye. They are blinded. They compare eyes without knowing which one received the TXA. Receives: Drug: Tranexamic acid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in bruising
patients are given a survey to rate bruising on each side, change will be assessed from different time periods
Measured: Surveys will be completed by patients at 1 week, 1 month, 3 months post-operatively
change in bruising a survey to rate pain
patients are given a survey to rate pain on each side, change will be assessed from different time periods
Measured: Surveys will be completed by patients at 1 week, 1 month, 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start20 Feb 2020
- Primary completion20 Jul 2023 (estimated)
- Study completion20 Sep 2023 (estimated)
Why it stopped: Stopped study due to pharmacy issues before treating patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each patient is blinded to which eye receives TXA. All patients have both eyes injected with LA, and one eye injected with TXA.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Sidle, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724772
- Sponsor's protocol ID
- STU00211373
- Status last verified
- Jul 2024
- First submitted
- 5 Jan 2021
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes Following Upper Lid Blepharoplasty With and Without Tranexamic Acid as an Additive to Traditional Local Anesthetic.
- ClinicalTrials.gov ID
- NCT04724772
- Acronym / sponsor ID
- STU00211373
- Conditions
- Pain, Postoperative, Bruising
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Stopped study due to pharmacy issues before treating patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 20 Jul 2023 (estimated)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 26 Jan 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 goal of this investigation is to assess whether or not there is a significant difference in the presence and/or degree of post-operative ecchymosis, pain, and edema between groups of patients undergoing upper lid blepharoplasty with traditional local anesthetic (LA) and those who receive tranexamic acid (TXA) in addition to traditional LA.
Detailed description
Blood clot formation involves a cascade of reactions that results in the production of thrombin, which converts fibrinogen into fibrin. In turn, fibrin aggregates and forms a clot. Hemostasis depends on a balance between this clotting cascade and the processes that break down clots, particularly the conversion of plasminogen to plasmin and plasmin's subsequent degradation of fibrin polymers. Tranexamic acid (TXA) is an agent, first patented in 1957, that competitively inhibits plasmin generation and activity.
As a result, TXA promotes clotting and, therein, hemostasis, making it useful for controlling surgical bleeding. (See figure below.) Indeed, a 2012 meta-analysis demonstrated that administering TXA intra- or perioperatively reduces the probability of receiving a blood transfusion by one-third.
Additionally, large trials have shown that TXA does not increase the risk of thromboembolic events in patients. One study noted that there was a slightly increased incidence of seizures in patients who received TXA, though this was limited to patients who underwent open-heart surgery, which is, itself, an independent risk factor for seizures. Another study halved the dose of TXA administered to its participants, but this did not reduce seizure risk amongst the participants. Thus, the data on this adverse effect remains inconclusive, and surgeons continue using TXA for its hemostatic effects, especially in cardiac and orthopedic surgeries. Given that facial plastic surgery does not incur the same sort of blood loss as cardiac or orthopedic surgery, efforts to describe TXA use in this field have focused on its established anti-inflammatory properties in addition to hemostasis. There are reports of TXA use in rhinoplasties, face lifts, and blepharoplasties; however, such reports are scarce, with randomized, double-blinded, controlled clinical trials even more so. Only one study has examined TXA use in blepharoplasties. In that study, 34 patients were randomized to receive an injection of lidocaine mixed with either TXA or saline. The authors did not find any significant difference in post-operative parameters including size of periocular ecchymoses and patient-reported pain level. Since the only randomized controlled trial investigating TXA use in blepharoplasty involved 34 participants, the investigators aim to add to the body of knowledge on this matter.
Furthermore, the investigator's study will be structured differently from that of Sagiv et al. Firstly, the patients will serve as their own controls, since we will inject one eyelid with a solution containing TXA and another with a placebo solution. This will help reduce bias between study groups that may have existed in Sagiv et al's trial. Secondly, the investigators will follow the patients for 3 months after the procedure, which is eleven weeks longer than the duration of follow-up amongst participants in Sagiv et al's trial. This will give the investigators an even better sense of TXA's impact on patients' post-operative courses. In summary, the investigators wish to characterize TXA's hemostatic and anti-inflammatory effects in patients who undergo blepharoplasty. Since there is currently only one publication that accomplishes this, the investigators' objective is to expand knowledge in this area so that surgeons performing facial plastic procedures can optimize patients' recovery and outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each patient is blinded to which eye receives TXA. All patients have both eyes injected with LA, and one eye injected with TXA.
| Arm | Type | Receives |
|---|---|---|
| Blepharoplasty patient | Experimental | Drug: Tranexamic acid injectionPatient receives LA in one eye and LA with TXA in the other eye. They are blinded. They compare eyes without knowing which one received the TXA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any adult patient who is undergoing upper lid blepharoplasty with author Douglas Sidle, MD and who is older than 18 years of age, fluent in English, not on any anticoagulant or antiplatelet medication (e.g. aspirin, clopidogrel, etc.), not diagnosed with a coagulation disorder, not pregnant, not undergoing a simultaneous procedure, and not a Feinberg School of Medicine (FSM) student or Northwestern Memorial (NM) employee.
Key exclusion criteria (1 listed)
- less than 18 years of age, not fluent in English, taking anticoagulant or antiplatelet, has coagulation disorder, pregnant, simultaneous procedure, FSM or NM student/employee
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 acid injectionInjection of tranexamic acid preoperatively | Drug | Blepharoplasty patient |
Primary outcome
change in bruising
Time frame: Surveys will be completed by patients at 1 week, 1 month, 3 months post-operatively
patients are given a survey to rate bruising on each side, change will be assessed from different time periods
change in bruising a survey to rate pain
Time frame: Surveys will be completed by patients at 1 week, 1 month, 3 months post-operatively
patients are given a survey to rate pain on each side, change will be assessed from different time periods
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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 injection in people with Pain, Postoperative and Bruising, run by Northwestern University at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 23 Jul 2024. 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 United States. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
change in bruising (time frame: Surveys will be completed by patients at 1 week, 1 month, 3 months post-operatively). 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 23 Jul 2024.