NCT03970213

Intravenous Tranexamic Acid During Rhytidectomy

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Glasgold Group Plastic Surgery · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bleeding
• Bruising Face
• Swelling Lips & Face

Interventions

Type	Name	Description
DRUG	Tranexamic Acid 100Mg/Ml Inj Vil 10Ml	IV TXA given during surgery
DRUG	Normal Saline 0.9% Infusion Solution Bag	IV saline given during surgery

Timeline

• Start date: 2019-05-30
• Primary completion: 2019-08-30
• Completion: 2019-08-30
• First posted: 2019-05-31
• Last updated: 2019-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study