Intravenous Tranexamic Acid During Rhytidectomy

Study Overview
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Brief Summary
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This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are subjectively rated and complications are noted.

Detailed Description
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This is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding is rated on a scale of mild, moderate, or severe and given a score of 1-3. Postoperative ecchymosis and edema are subjectively rated by both patient and surgeon on postoperative days 1, 6, and 9 using a similar mild/moderate/severe scale and scored 1-3, respectively. Any surgical or postoperative complications are noted. Scores are aggregated for statistical analysis.

Official Title
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Effects of Intravenous Tranexamic Acid During Rhytidectomy - a Randomized, Controlled, Double-blind Pilot Study

Conditions
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Bleeding, Bruising Face, Swelling Lips & Face

Intervention / Treatment
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* Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml
* Drug: Normal Saline 0.9% Infusion Solution Bag


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing rhytidectomy surgery at Glasgold Group Plastic Surgery Exclusion Criteria: History of bleeding disorder, history of thromboembolic events, history of seizure, active use of oral contraceptive pills or hormone replacement therapy, participant preference

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 4 hours later | Drug: Normal Saline 0.9% Infusion Solution Bag<br>* IV saline given during surgery<br>|
| Experimental: TXA Group<br>One gram of intravenous tranexamic acid (TXA) in normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 4 hours later | Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml<br>* IV TXA given during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative bleeding | Subjective measure of intraoperative blood loss (mild, moderate, or severe) | Surgical time | 
| Postoperative ecchymosis | Subjective measure of bruising rated as mild, moderate, or severe | Postoperative day 1 | 
| Postoperative ecchymosis | Subjective measure of bruising rated as mild, moderate, or severe | Postoperative day 6 | 
| Postoperative ecchymosis | Subjective measure of bruising rated as mild, moderate, or severe | Postoperative day 9 | 
| Postoperative edema | Subjective measure of swelling rated as mild, moderate, or severe | Postoperative day 1 | 
| Postoperative edema | Subjective measure of swelling rated as mild, moderate, or severe | Postoperative day 6 | 
| Postoperative edema | Subjective measure of swelling rated as mild, moderate, or severe | Postoperative day 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hematoma/seroma | Documentation of any postoperative collections seen during the first 10 days following surgery | 10 days postoperative | 
| Complications | Documentation of any surgical or postoperative complications | 10 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tranexamic acid, Rhytidectomy, Facelift