Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT05774717
Phase
PHASE1
Status
Recruiting
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Conditions

  • Postoperative Blood Loss
  • Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Tranexamic acid — DRUG
    1 gram IV (intravenous) tranexamic acid administered in the operating room just prior to starting the case (10 minutes), at time that routine preoperative antibiotic is given.

Study Details

This study will be a prospective randomized study to evaluate the effect of tranexamic acid (TXA) use on intraoperative and postoperative outcomes among patients undergoing rhinoplasty by two Facial Plastic surgeons at Vanderbilt. Outcomes will include intra- and post-operative bleeding and postoperative bruising and swelling.

Key Dates

Start date
Apr 1, 2023
Status verified
Apr 2026
Primary completion
Apr 1, 2029
Completion
Apr 1, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Tranexamic Acid
    Patients receive 1 gram IV tranexamic acid in the operating room prior to surgical incision.
  • No Intervention: Control
    Routine care, no tranexamic acid given.

Primary Outcome Measure

Intraoperative bleeding as measured by the weight of surgical sponges used [ Time Frame: During surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Shiayin F Yang, MD
[email protected]
(615) 322-6180
Elizabeth S Longino, MD
[email protected]
(615) 322-6180

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By research site
Vanderbilt University Medical Center· Nashville, TN

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