RECRUITING

Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis

Talk to us

Conditions

SurgeryPostoperative Blood Loss

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis

Quick Facts

Study Start:2023-04-01
Study Completion:2025-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05774717

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults at least 18 years of age who elect to undergo cosmetic or functional open primary rhinoplasty with osteotomies (repositioning the nasal bones) by Drs. Yang or Patel at VUMC.
  2. * No other facial plastics procedure nor sinus surgery performed simultaneously
  3. * Lack all the below Exclusion Criteria
  1. * Known allergy to TXA (tranexamic acid)
  2. * Intracranial bleeding
  3. * Known defective color vision
  4. * History of venous or arterial thromboembolism
  5. * Active thromboembolic disease
  6. * Severe renal impairment (diagnosis of chronic kidney disease)
  7. * History of coagulation disorder
  8. * Known thrombocytopenia (platelets \<150,000)
  9. * Current use of anticoagulant (blood thinner)
  10. * Uncontrolled DM (diabetes mellitus) preventing use of dexamethasone in the perioperative period
  11. * Cardiac arrhythmia
  12. * History of AMI (acute myocardial infarction), stroke, seizure, liver failure
  13. * Laboratory results showing platelets \<150,000, PT (prothrombin time) \>45, INR (international normalized ratio) \>1.2, seizure disorder

Contacts and Locations

Study Contact

Shiayin F Yang, MD
CONTACT
(615) 322-6180
elizabeth.d.stephenson.1@vumc.org
Elizabeth S Longino, MD
CONTACT
(615) 322-6180
elizabeth.d.stephenson.1@vumc.org

Principal Investigator

Shiayin F Yang, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Shiayin F Yang, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-01
Study Completion Date2025-02-01

Study Record Updates

Study Start Date2023-04-01
Study Completion Date2025-02-01

Terms related to this study

Additional Relevant MeSH Terms

  • Surgery
  • Postoperative Blood Loss