Intravenous Tranexamic Acid During Rhytidectomy

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

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.

Study Overview

• Status: Unknown
• Conditions: Bleeding; Bruising Face; Swelling Lips & Face
• Intervention / Treatment: Drug: Normal Saline 0.9% Infusion Solution Bag; Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Glasgold Group Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 4 hours later	Drug: Normal Saline 0.9% Infusion Solution Bag; IV saline given during surgery
Experimental: TXA Group; 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	Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml; IV TXA given during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative bleeding	Subjective measure of intraoperative blood loss (mild, moderate, or severe)	Surgical time
Postoperative ecchymosis	Subjective measure of bruising rated as mild, moderate, or severe	Postoperative day 1
Postoperative ecchymosis	Subjective measure of bruising rated as mild, moderate, or severe	Postoperative day 6
Postoperative ecchymosis	Subjective measure of bruising rated as mild, moderate, or severe	Postoperative day 9
Postoperative edema	Subjective measure of swelling rated as mild, moderate, or severe	Postoperative day 1
Postoperative edema	Subjective measure of swelling rated as mild, moderate, or severe	Postoperative day 6
Postoperative edema	Subjective measure of swelling rated as mild, moderate, or severe	Postoperative day 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative hematoma/seroma	Documentation of any postoperative collections seen during the first 10 days following surgery	10 days postoperative
Complications	Documentation of any surgical or postoperative complications	10 days postoperative

Collaborators and Investigators

• Sponsor: Glasgold Group Plastic Surgery
• Investigators: Study Director: Mark J Glasgold, MD, Glasgold Group Plastic Surgery

Study record dates

Study Major Dates

• Study Start (Anticipated): May 30, 2019
• Primary Completion (Anticipated): August 30, 2019
• Study Completion (Anticipated): August 30, 2019

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2019
• Last Update Submitted That Met QC Criteria: May 30, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Tranexamic acid; Facelift; Rhytidectomy
• Additional Relevant MeSH Terms: Wounds and Injuries; Wounds, Nonpenetrating; Contusions; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: GGPS19-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient demographics, surgical procedure performed, primary and secondary outcomes
• IPD Sharing Time Frame: Will be made available via publication
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No