Back to resultsIntravenous Tranexamic Acid During Rhytidectomy
Primary Purpose
Bleeding, Bruising Face, Swelling Lips & Face
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid 100Mg/Ml Inj Vil 10Ml
Normal Saline 0.9% Infusion Solution Bag
Sponsored by
About this trial
This is an interventional other trial for Bleeding focused on measuring Tranexamic acid, Rhytidectomy, Facelift
Eligibility Criteria
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
Sites / Locations
- Glasgold Group Plastic Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control Group
TXA Group
Arm Description
Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 4 hours later
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
Outcomes
Primary Outcome Measures
Intraoperative bleeding
Subjective measure of intraoperative blood loss (mild, moderate, or severe)
Postoperative ecchymosis
Subjective measure of bruising rated as mild, moderate, or severe
Postoperative ecchymosis
Subjective measure of bruising rated as mild, moderate, or severe
Postoperative ecchymosis
Subjective measure of bruising rated as mild, moderate, or severe
Postoperative edema
Subjective measure of swelling rated as mild, moderate, or severe
Postoperative edema
Subjective measure of swelling rated as mild, moderate, or severe
Postoperative edema
Subjective measure of swelling rated as mild, moderate, or severe
Secondary Outcome Measures
Postoperative hematoma/seroma
Documentation of any postoperative collections seen during the first 10 days following surgery
Complications
Documentation of any surgical or postoperative complications
Full Information
NCT ID
NCT03970213
First Posted
May 29, 2019
Last Updated
May 30, 2019
Sponsor
Glasgold Group Plastic Surgery
1. Study Identification
Unique Protocol Identification Number
NCT03970213
Brief Title
Intravenous Tranexamic Acid During Rhytidectomy
Official Title
Effects of Intravenous Tranexamic Acid During Rhytidectomy - a Randomized, Controlled, Double-blind Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 30, 2019 (Anticipated)
Primary Completion Date
August 30, 2019 (Anticipated)
Study Completion Date
August 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glasgold Group Plastic Surgery
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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding, Bruising Face, Swelling Lips & Face
Keywords
Tranexamic acid, Rhytidectomy, Facelift
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Only the CRNA who is administering the medications is unmasked until completion of the data collection period.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 4 hours later
Arm Title
TXA Group
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid 100Mg/Ml Inj Vil 10Ml
Intervention Description
IV TXA given during surgery
Intervention Type
Drug
Intervention Name(s)
Normal Saline 0.9% Infusion Solution Bag
Intervention Description
IV saline given during surgery
Primary Outcome Measure Information:
Title
Intraoperative bleeding
Description
Subjective measure of intraoperative blood loss (mild, moderate, or severe)
Time Frame
Surgical time
Title
Postoperative ecchymosis
Description
Subjective measure of bruising rated as mild, moderate, or severe
Time Frame
Postoperative day 1
Title
Postoperative ecchymosis
Description
Subjective measure of bruising rated as mild, moderate, or severe
Time Frame
Postoperative day 6
Title
Postoperative ecchymosis
Description
Subjective measure of bruising rated as mild, moderate, or severe
Time Frame
Postoperative day 9
Title
Postoperative edema
Description
Subjective measure of swelling rated as mild, moderate, or severe
Time Frame
Postoperative day 1
Title
Postoperative edema
Description
Subjective measure of swelling rated as mild, moderate, or severe
Time Frame
Postoperative day 6
Title
Postoperative edema
Description
Subjective measure of swelling rated as mild, moderate, or severe
Time Frame
Postoperative day 9
Secondary Outcome Measure Information:
Title
Postoperative hematoma/seroma
Description
Documentation of any postoperative collections seen during the first 10 days following surgery
Time Frame
10 days postoperative
Title
Complications
Description
Documentation of any surgical or postoperative complications
Time Frame
10 days postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark J Glasgold, MD
Phone
732-846-6540
Email
mglasgold@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Justin C Cohen, MD
Phone
732-846-6540
Email
justinccohen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Glasgold, MD
Organizational Affiliation
Glasgold Group Plastic Surgery
Official's Role
Study Director
Facility Information:
Facility Name
Glasgold Group Plastic Surgery
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark J Glasgold, MD
Phone
732-846-6540
Email
mglasgold@gmail.com
First Name & Middle Initial & Last Name & Degree
Robert A Glasgold, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient demographics, surgical procedure performed, primary and secondary outcomes
IPD Sharing Time Frame
Will be made available via publication
Learn more about this trial
Intravenous Tranexamic Acid During Rhytidectomy
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