Eyelid Diseases, Hemorrhage, Periorbital Disorder, Surgical Blood Loss
Conditions
Brief summary
This study investigates the effect of tranexamic acid, a medication that helps reduce bleeding, in patients undergoing surgeries around their eyes.
Interventions
DRUGTranexamic acid
100 mg/mL Tranexamic acid with lidocaine with 1:100,000 epinephrine in 1:1 manner administered subcutaneously
DRUGPlacebo
Lidocaine with 1:100,000 epinephrine mixed with 1:1 Basal Saline Solution (BSS) administered subcutaneously
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults age 18 and above undergoing periorbital oculoplastic surgery including but not limited to upper and lower blepharoplasty, four lid procedures, or dacryocystorhinostomy (DCR).
Exclusion criteria
* \- Adults unable to consent * Individuals less than 18 years of age * Prisoners * Pregnant women. * Known contradictions or sensitivities to study medication (tranexamic acid) * Patients with known prior thromboembolic events * Previous eyelid surgery or same-side DCR (RE-DCR) * Has any type of coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative patient ecchymosis | Up to 3 months | Ecchymosis will be graded 0-3 based on location and degree based on a previously reported validated scale (higher scores with more ecchymosis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative patient chemosis | Up to 3 months | Chemosis, swelling of the eyes, will be measured on a scale of 0-4 (higher scores, more edema) |
| Eyelid edema | Up to 3 months | Measurement includes through Surgeon Periorbital Ration of Edema and Ecchymosis (SPREE), which has a total score ranging from 1 to 4 with the higher score indicating more severe eyelid edema. |
| Intraoperative patient bleeding | Postoperative day 0 (day of surgery) | The amount of blood loss intraoperatively will be measured using a scale for blood soaked materials. |
| Physician Perception of Intraoperative Bleeding | Postoperative day 0 (day of surgery) | The primary surgeon will subjectively rank the efficacy of hemostasis on a scale of 1-4 \[excellent (1), good (2), moderate (3), or poor (4) \] immediately after the operation. |
| Patient-perceived outcomes | Up to 3 months | Patients will complete a validated FACE-Q survey which has a raw score converted to a scaled score of from 0-100, with higher scores indicating a better outcome. |
Outcome results
None listed