Intravenous Tranexamic Acid During Rhytidectomy

Glasgold Group Plastic Surgery

Status and phase: Unknown; Phase 4

Conditions: Bruising Face; Swelling Lips & Face; Bleeding

Treatments: Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml; Drug: Normal Saline 0.9% Infusion Solution Bag

Study type: Interventional

Funder types: Other

Identifiers

NCT03970213

GGPS19-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal Saline 0.9% Infusion Solution Bag

TXA Group

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml