Intravenous Tranexamic Acid During Rhytidectomy

Phase 4

• Conditions: Bruising Face; Bleeding; Swelling Lips & Face
• Interventions: Drug: Normal Saline 0.9% Infusion Solution Bag; Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml

• Registration Number: NCT03970213
• Lead Sponsor: Glasgold Group Plastic Surgery

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-29
• Study Start: 2019-05-30
• Study First Submitted QC: 2019-05-30
• Last Update Submitted: 2019-05-30
• Study First Posted: 2019-05-31
• Last Update Posted: 2019-05-31
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Normal Saline 0.9% Infusion Solution Bag	Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 4 hours later
TXA Group	Tranexamic Acid 100Mg/Ml Inj Vil 10Ml	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

Primary Outcome Measures

Name	Time	Method
Intraoperative bleeding	Surgical time	Subjective measure of intraoperative blood loss (mild, moderate, or severe)
Postoperative ecchymosis	Postoperative day 9	Subjective measure of bruising rated as mild, moderate, or severe
Postoperative edema	Postoperative day 9	Subjective measure of swelling rated as mild, moderate, or severe

Secondary Outcome Measures

Name	Time	Method
Postoperative hematoma/seroma	10 days postoperative	Documentation of any postoperative collections seen during the first 10 days following surgery
Complications	10 days postoperative	Documentation of any surgical or postoperative complications

Trial Locations

Locations (1)

Glasgold Group Plastic Surgery; 🇺🇸 Princeton, New Jersey, United States