NCT03970213

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

May 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

May 29, 2019

Last Update Submit

May 30, 2019

Conditions

BleedingBruising FaceSwelling Lips & Face

Keywords

Tranexamic acidRhytidectomyFacelift

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (2)

  • Postoperative hematoma/seroma

    10 days postoperative

  • Complications

    10 days postoperative

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

TXA Group

EXPERIMENTAL

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

Interventions

Tranexamic Acid 100Mg/Ml Inj Vil 10MlDRUG

IV TXA given during surgery

TXA Group
Normal Saline 0.9% Infusion Solution BagDRUG

IV saline given during surgery

Control Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing rhytidectomy surgery at Glasgold Group Plastic Surgery

You may not qualify if:

  • History of bleeding disorder, history of thromboembolic events, history of seizure, active use of oral contraceptive pills or hormone replacement therapy, participant preference

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glasgold Group Plastic Surgery

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

HemorrhageFacies

Interventions

Tranexamic AcidSaline Solution

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Mark J Glasgold, MD

    Glasgold Group Plastic Surgery

    STUDY DIRECTOR

Central Study Contacts

Mark J Glasgold, MD

CONTACT

732-846-6540mglasgold@gmail.com

Justin C Cohen, MD

CONTACT

732-846-6540justinccohen@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Only the CRNA who is administering the medications is unmasked until completion of the data collection period.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized, double-blind
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2019

First Posted

May 31, 2019

Study Start

May 30, 2019

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

May 31, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

Patient demographics, surgical procedure performed, primary and secondary outcomes

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Will be made available via publication

Locations

US(1)