Trial | NCT03970213  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    40
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.
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 Started
May 30
2019
Anticipated
Primary Completion
Aug 30
2019
Anticipated
Study Completion
Aug 30
2019
Anticipated
Last Update
May 31
2019

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

Control Group Placebo Comparator

Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 4 hours later

TXA Group Experimental

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

Criteria 

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
No Results Posted