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Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis

Primary Purpose

Surgery, Postoperative Blood Loss

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tranexamic acid
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. No other facial plastics procedure nor sinus surgery performed simultaneously Lack all the below Exclusion Criteria Exclusion Criteria: Known allergy to TXA (tranexamic acid) Intracranial bleeding Known defective color vision History of venous or arterial thromboembolism Active thromboembolic disease Severe renal impairment (diagnosis of chronic kidney disease) History of coagulation disorder Known thrombocytopenia (platelets <150,000) Current use of anticoagulant (blood thinner) Uncontrolled DM (diabetes mellitus) preventing use of dexamethasone in the perioperative period Cardiac arrhythmia History of AMI (acute myocardial infarction), stroke, seizure, liver failure Laboratory results showing platelets <150,000, PT (prothrombin time) >45, INR (international normalized ratio) >1.2, seizure disorder

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tranexamic Acid

Control

Arm Description

Patients receive 1 gram IV tranexamic acid in the operating room prior to surgical incision.

Routine care, no tranexamic acid given.

Outcomes

Primary Outcome Measures

Intraoperative bleeding as measured by the weight of surgical sponges used
Weight of surgical sponges used (grams)
Intraoperative bleeding as measured by the volume of blood in suction canister
Volume of blood in suction canister (Milliliters)
Postoperative bleeding as measured by patient-rated bleeding on Visual Analog Scale (VAS)
A single patient-answered question visual analog scale (VAS) used to measure the amount of post-operative bleeding from the nose the participant experienced (1 to 5 scale with 5 being the most)
Postoperative edema
Swelling around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most)
Postoperative ecchymosis
Bruising around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most)
Postoperative bleeding as measured by the number of medical interventions needed to control bleeding
Number of interventions required to control bleeding (surgical or procedural interventions)

Secondary Outcome Measures

Full Information

First Posted
October 12, 2022
Last Updated
June 16, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05774717
Brief Title
Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis
Official Title
Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

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.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
TXA is an antifibrinolytic agent that acts to decrease bleeding by stabilizing the fibrin matrix involved in the clotting cascade. The use of TXA, oral or intravenous, has been extensively used and described in the literature to prevent exsanguination in trauma and in various surgical procedures, as well as for heavy menstrual bleeding. It has been used in the perioperative period during various nasal and sinus surgery, and current research in rhinoplasty suggests that its use may decrease intraoperative bleeding and postoperative eye swelling and bruising. Currently, IV TXA is used at this institution in some cases by some surgeons in the perioperative period in rhinoplasty surgery, though its used is not standardized and has not been studied. This study will randomize patients undergoing rhinoplasty, with consent, to receive TXA or placebo in the perioperative period. The investigators anticipate collecting 60-100 patients. Outcomes will include intraoperative bleeding, postoperative swelling and bruising (both subjective and based on blinded reviewer analysis of postoperative photographs). TXA has been used in the perioperative period during various nasal and sinus surgery, and current research in rhinoplasty suggests that its use may decrease intraoperative bleeding and postoperative eye swelling and bruising. In these studies, TXA has been given in intravenous and/or oral form in 1-3 doses in the perioperative period, and there have been no serious adverse effects reported. IV TXA is also FDA approved for use at time of tooth extraction to decrease bleeding, and PO TXA is approved use during the menstrual cycle to decrease heavy menstrual bleeding. There are countless studies in the literature supporting use of both IV and PO TXA in trauma, orthopedic and spine surgery and neurosurgery, and it is widely used in clinical practice in these disciplines. It's use in rhinoplasty is growing, yet has not been studied in larger groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Postoperative Blood Loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
One group receives tranexamic acid prior to surgery, one group receives nothing (routine care).
Masking
None (Open Label)
Masking Description
Provider will order tranexamic acid based based on even versus odd last digit of medical record number (MRN). Patient will be blinded, as will all personnel analyzing postoperative photographs and other data.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic Acid
Arm Type
Experimental
Arm Description
Patients receive 1 gram IV tranexamic acid in the operating room prior to surgical incision.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine care, no tranexamic acid given.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
TXA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraoperative bleeding as measured by the weight of surgical sponges used
Description
Weight of surgical sponges used (grams)
Time Frame
During surgery
Title
Intraoperative bleeding as measured by the volume of blood in suction canister
Description
Volume of blood in suction canister (Milliliters)
Time Frame
Intraoperative
Title
Postoperative bleeding as measured by patient-rated bleeding on Visual Analog Scale (VAS)
Description
A single patient-answered question visual analog scale (VAS) used to measure the amount of post-operative bleeding from the nose the participant experienced (1 to 5 scale with 5 being the most)
Time Frame
Up to one week following surgery.
Title
Postoperative edema
Description
Swelling around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most)
Time Frame
Up to one week following surgery
Title
Postoperative ecchymosis
Description
Bruising around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most)
Time Frame
Up to one week following surgery
Title
Postoperative bleeding as measured by the number of medical interventions needed to control bleeding
Description
Number of interventions required to control bleeding (surgical or procedural interventions)
Time Frame
Up to one week following surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. No other facial plastics procedure nor sinus surgery performed simultaneously Lack all the below Exclusion Criteria Exclusion Criteria: Known allergy to TXA (tranexamic acid) Intracranial bleeding Known defective color vision History of venous or arterial thromboembolism Active thromboembolic disease Severe renal impairment (diagnosis of chronic kidney disease) History of coagulation disorder Known thrombocytopenia (platelets <150,000) Current use of anticoagulant (blood thinner) Uncontrolled DM (diabetes mellitus) preventing use of dexamethasone in the perioperative period Cardiac arrhythmia History of AMI (acute myocardial infarction), stroke, seizure, liver failure Laboratory results showing platelets <150,000, PT (prothrombin time) >45, INR (international normalized ratio) >1.2, seizure disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiayin F Yang, MD
Phone
(615) 322-6180
Email
elizabeth.d.stephenson.1@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth S Longino, MD
Phone
(615) 322-6180
Email
elizabeth.d.stephenson.1@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiayin F Yang, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiayin F Yang, MD
Phone
615-322-6180
Email
elizabeth.d.stephenson.1@vumc.org
First Name & Middle Initial & Last Name & Degree
Elizabeth S Longino, MD
Phone
(615) 322-6180
Email
elizabeth.d.stephenson.1@vumc.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan at this time to share.
Citations:
PubMed Identifier
33208696
Citation
Avci H. The Effect of Different Dose Regimens of Tranexamic Acid in Reducing Blood Loss in Rhinoplasty: A Prospective Randomized Controlled Study. J Craniofac Surg. 2021 Jul-Aug 01;32(5):e442-e444. doi: 10.1097/SCS.0000000000007247.
Results Reference
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PubMed Identifier
30098161
Citation
de Vasconcellos SJA, do Nascimento-Junior EM, de Aguiar Menezes MV, Tavares Mendes ML, de Souza Dantas R, Martins-Filho PRS. Preoperative Tranexamic Acid for Treatment of Bleeding, Edema, and Ecchymosis in Patients Undergoing Rhinoplasty: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2018 Sep 1;144(9):816-823. doi: 10.1001/jamaoto.2018.1381.
Results Reference
background
PubMed Identifier
31204198
Citation
Zaman SU, Zakir I, Faraz Q, Akhtar S, Nawaz A, Adeel M. Effect of single-dose intravenous tranexamic acid on postoperative nasal bleed in septoplasty. Eur Ann Otorhinolaryngol Head Neck Dis. 2019 Nov;136(6):435-438. doi: 10.1016/j.anorl.2018.10.019. Epub 2019 Jun 14.
Results Reference
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PubMed Identifier
33791652
Citation
Locketz GD, Lozada KN, Bloom JD. Tranexamic Acid in Aesthetic Facial Plastic Surgery: A Systematic Review of Evidence, Applications, and Outcomes. Aesthet Surg J Open Forum. 2020 Jun 14;2(3):ojaa029. doi: 10.1093/asjof/ojaa029. eCollection 2020 Sep.
Results Reference
background
PubMed Identifier
35031005
Citation
Jouybar R, Nemati M, Asmarian N. Comparison of the effects of remifentanil and dexmedetomidine on surgeon satisfaction with surgical field visualization and intraoperative bleeding during rhinoplasty. BMC Anesthesiol. 2022 Jan 14;22(1):24. doi: 10.1186/s12871-021-01546-9.
Results Reference
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Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis

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