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Research team dissembled because of no funding.
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This study investigates the effect of tranexamic acid, a medication that helps reduce bleeding, in patients undergoing surgeries around their eyes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid Group | Experimental | Participants undergoing standard of care periorbital procedures will be randomized to receive tranexamic acid with lidocaine/epinephrine on one of their eyelids at the beginning of the scheduled operation before incision. |
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| Placebo Group | Placebo Comparator | Participants undergoing standard of care periorbital procedures will be randomized to receive balanced salt solution with lidocaine/epinephrine on one of their eyelids at the beginning of the scheduled operation before incision. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | 100 mg/mL Tranexamic acid with lidocaine with 1:100,000 epinephrine in 1:1 manner administered subcutaneously |
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| Measure | Description | Time Frame |
|---|---|---|
| Postoperative patient ecchymosis | Ecchymosis will be graded 0-3 based on location and degree based on a previously reported validated scale (higher scores with more ecchymosis) | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative patient chemosis | Chemosis, swelling of the eyes, will be measured on a scale of 0-4 (higher scores, more edema) | Up to 3 months |
| Eyelid edema | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy W Lee, MD | University of Miami | Principal Investigator |
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| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D006470 | Hemorrhage |
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Lidocaine with 1:100,000 epinephrine mixed with 1:1 Basal Saline Solution (BSS) administered subcutaneously |
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| Up to 3 months |
| Intraoperative patient bleeding | The amount of blood loss intraoperatively will be measured using a scale for blood soaked materials. | Postoperative day 0 (day of surgery) |
| Physician Perception of Intraoperative Bleeding | 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. | Postoperative day 0 (day of surgery) |
| Patient-perceived outcomes | 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. | Up to 3 months |