Brief Summary
Tranexamic acid (TXA) is a synthetic reversible competitive inhibitor to plasminogen lysine receptor, which prevents plasmin formation and stabilizes the fibrin matrix, thus reducing bleeding. While recent studies have demonstrated the antifibrinolytic benefits of TXA in obstetric and gynecologic conditions, traumatic hemorrhage, cardiac surgery, total knee arthroplasty, and more, there is a paucity of clinical data on TXA use in plastic surgery. The aim of this study is to evaluate the effect of local and systemic TXA on postoperative periocular ecchymosis/edema in orbital surgery.
Brief Title
The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery
Detailed Description
Patients, who will be undergoing orbital surgery anyways, will be given the option to participate in the study. Informed consent will be obtained in clinic during the preoperative consultation. On the day of surgery in the preoperative suite, study participants will be randomly allocated to one of three groups via computer-generated random numbers:
Group 1: will receive 1g intravenous tranexamic acid (Pfizer, New York, NY) 20 minutes prior to surgery. Group 2: will receive 1.7 mL of subcutaneous tranexamic acid 100 mg/mL (Pfizer, New York, NY) with local anesthetic to the orbit two minutes prior to incision. Group 3: will receive intravenous normal saline and subcutaneous local anesthetic (i.e. standard procedure) as control group.
Twenty minutes before incision time, all patients will receive an intravenous solution. This will be either saline (placebo, participants in group 2 and 3) or 1g of tranexamic acid (participants in group 1). All operations will be performed using the standard of care technique and surgical instruments. All surgery will be performed under intravenous sedation with local anesthesia. Standard skin marking will be drawn, then the surgeon will inject each patient subcutaneously with either (1) a 5 cc mixture of TXA (100 mg/mL) mixed with 2% lidocaine with epinephrine and 0.5% marcaine with epinephrine in a 1:1:1 ratio (local TXA, Group 2) or (2) normal saline 0.9% sodium chloride mixed with 2% lidocaine with epinephrine and 0.5% marcaine with epinephrine in a 1:1:1 ratio (Group 1, Group 3). Degree of ecchymosis and edema in the postoperative photographs will be assessed separately by two graders. Graders will be blinded to treatment groups, and the photos will be completely deidentified.
Immediately following the procedure, the surgeon will take standardized photographs. The surgeon will also take standardized photographs at the regular 7-day postoperative visit. These photos will be deidentified and analyzed for degree of ecchymosis and edema by two blinded graders who will rate the photos using a standard five point grading scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = profound) as described in the respective outcome measures.
Group 1: will receive 1g intravenous tranexamic acid (Pfizer, New York, NY) 20 minutes prior to surgery. Group 2: will receive 1.7 mL of subcutaneous tranexamic acid 100 mg/mL (Pfizer, New York, NY) with local anesthetic to the orbit two minutes prior to incision. Group 3: will receive intravenous normal saline and subcutaneous local anesthetic (i.e. standard procedure) as control group.
Twenty minutes before incision time, all patients will receive an intravenous solution. This will be either saline (placebo, participants in group 2 and 3) or 1g of tranexamic acid (participants in group 1). All operations will be performed using the standard of care technique and surgical instruments. All surgery will be performed under intravenous sedation with local anesthesia. Standard skin marking will be drawn, then the surgeon will inject each patient subcutaneously with either (1) a 5 cc mixture of TXA (100 mg/mL) mixed with 2% lidocaine with epinephrine and 0.5% marcaine with epinephrine in a 1:1:1 ratio (local TXA, Group 2) or (2) normal saline 0.9% sodium chloride mixed with 2% lidocaine with epinephrine and 0.5% marcaine with epinephrine in a 1:1:1 ratio (Group 1, Group 3). Degree of ecchymosis and edema in the postoperative photographs will be assessed separately by two graders. Graders will be blinded to treatment groups, and the photos will be completely deidentified.
Immediately following the procedure, the surgeon will take standardized photographs. The surgeon will also take standardized photographs at the regular 7-day postoperative visit. These photos will be deidentified and analyzed for degree of ecchymosis and edema by two blinded graders who will rate the photos using a standard five point grading scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = profound) as described in the respective outcome measures.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
718-920-4609
Central Contact Email
abarmett@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
Orbital Edema
Orbital Ecchymosis
Eligibility Criteria
Inclusion Criteria:
* Patients undergoing orbital surgery (decompressions, fracture repairs, enucleations, eviscerations, etc.)
* Patients who are at least 18 years of age
* Patients that have the capacity to consent
Exclusion Criteria:
* Any history of previous orbital surgery
* Any patient undergoing multiple simultaneous periocular surgical procedures
* Any patient with active infection
* History of stroke or seizure
* History of bleeding/clotting disorder
* Patients who do not comply with the required postoperative follow-up schedule
* Patients who are allergic to tranexamic acid
* Patients who have taken anticoagulant/antiplatelet agents (including aspirin) within 7 days prior to surgery
* Patients who have periocular ecchymosis or edema prior to surgery
* Patients undergoing orbital surgery (decompressions, fracture repairs, enucleations, eviscerations, etc.)
* Patients who are at least 18 years of age
* Patients that have the capacity to consent
Exclusion Criteria:
* Any history of previous orbital surgery
* Any patient undergoing multiple simultaneous periocular surgical procedures
* Any patient with active infection
* History of stroke or seizure
* History of bleeding/clotting disorder
* Patients who do not comply with the required postoperative follow-up schedule
* Patients who are allergic to tranexamic acid
* Patients who have taken anticoagulant/antiplatelet agents (including aspirin) within 7 days prior to surgery
* Patients who have periocular ecchymosis or edema prior to surgery
Inclusion Criteria
Inclusion Criteria:
* Patients undergoing orbital surgery (decompressions, fracture repairs, enucleations, eviscerations, etc.)
* Patients who are at least 18 years of age
* Patients that have the capacity to consent
* Patients undergoing orbital surgery (decompressions, fracture repairs, enucleations, eviscerations, etc.)
* Patients who are at least 18 years of age
* Patients that have the capacity to consent
Gender
All
Gender Based
false
Keywords
Orbital Surgery
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06450392
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2024-15945
Overall Status
Recruiting
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery - a Prospective, Multicenter, Randomized, Double-blinded, Control Trial
Primary Outcomes
Outcome Description
Degree of ecchymosis on postoperative day zero (POD0) and postoperative day 7 (POD7) as graded on a 5 point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = profound) by two independent graders. The two scores will be averaged for inclusion in analysis. Scores will be aggregated to calculate means and standard deviations (SDs) for each group. Higher scores are associated with increased severity of ecchymosis.
Outcome Measure
Degree of Ecchymosis
Outcome Time Frame
0 days and 7 days postoperatively
Outcome Description
Degree of edema on postoperative day zero (POD0) and postoperative day 7 (POD7) as graded on a 5 point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = profound) by two independent graders. The two scores will be averaged for inclusion in analysis. Scores will be aggregated to calculate means and standard deviations (SDs) for each group. Higher scores are associated with increased severity of edema.
Outcome Measure
Degree of Edema
Outcome Time Frame
0 days and 7 days postoperatively
Secondary Outcomes
Outcome Description
Patients asked how satisfied they are with their edema postoperatively. Responses will be scored as 0 (not satisfied at all), 1 (somewhat unsatisfied), 2 (neutral), 3 (somewhat satisfied), or 4 (completely satisfied). Responses will be summed and mean scores and standard deviations (SDs) will be reported for each group. Higher scores correlate with increased degree of satisfaction.
Outcome Time Frame
7 days postoperatively
Outcome Measure
Patient Satisfaction with edema
Outcome Description
Patients asked how satisfied they are with their ecchymosis postoperatively. Responses will be scored as 0 (not satisfied at all), 1 (somewhat unsatisfied), 2 (neutral), 3 (somewhat satisfied), or 4 (completely satisfied). Responses will be summed and mean scores and standard deviations (SDs) will be reported for each group. Higher scores correlate with increased degree of satisfaction.
Outcome Time Frame
7 days postoperatively
Outcome Measure
Patient Satisfaction with ecchymosis
Outcome Description
Patients will be asked if they had any seizure, focal weakness, lower extremity pain, difficulty breathing, chest pain, or any emergency room visit (to assess for adverse effects including thromboembolic event or seizure). Responses will be recorded as either "Thromboembolic event occurred" or "Thromboembolic event did not occur." Seizure events will be recorded in the same way. The number of patients with thromboembolic events and/or seizures will be summarized by the study arm.
Outcome Time Frame
7 days postoperatively
Outcome Measure
Other side effects
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Anne Barmettler
Investigator Email
abarmett@montefiore.org
Investigator Department
Ophthalmology & Visual Sciences
Investigator Sponsor Organization
External
Study Department
Ophthalmology and Visual Sciences
Study Division
Not Applicable
MeSH Terms
TRANEXAMIC ACID
SALINE SOLUTION
CYCLOHEXANECARBOXYLIC ACIDS
ACIDS, CARBOCYCLIC
CARBOXYLIC ACIDS
ORGANIC CHEMICALS
CRYSTALLOID SOLUTIONS
ISOTONIC SOLUTIONS
SOLUTIONS
PHARMACEUTICAL PREPARATIONS