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Intravenous Tranexamic Acid During Rhytidectomy

NCT ID: NCT03970213

Last Updated: 2019-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-30

Study Completion Date

2019-08-30

Brief Summary

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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

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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.

Conditions

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Bleeding Bruising Face Swelling Lips & Face

Keywords

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Tranexamic acid Rhytidectomy Facelift

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Only the CRNA who is administering the medications is unmasked until completion of the data collection period.

Study Groups

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Control Group

Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 4 hours later

Group Type PLACEBO_COMPARATOR

Normal Saline 0.9% Infusion Solution Bag

Intervention Type DRUG

IV saline given during surgery

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

Group Type EXPERIMENTAL

Tranexamic Acid 100Mg/Ml Inj Vil 10Ml

Intervention Type DRUG

IV TXA given during surgery

Interventions

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Tranexamic Acid 100Mg/Ml Inj Vil 10Ml

IV TXA given during surgery

Intervention Type DRUG

Normal Saline 0.9% Infusion Solution Bag

IV saline given during surgery

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Glasgold Group Plastic Surgery

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark J Glasgold, MD

Role: STUDY_DIRECTOR

Glasgold Group Plastic Surgery

Locations

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Glasgold Group Plastic Surgery

Princeton, New Jersey, United States

Site Status

Countries

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United States

Central Contacts

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Mark J Glasgold, MD

Role: CONTACT

Phone: 732-846-6540

Email: [email protected]

Justin C Cohen, MD

Role: CONTACT

Phone: 732-846-6540

Email: [email protected]

Facility Contacts

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Mark J Glasgold, MD

Role: primary

Other Identifiers

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GGPS19-01

Identifier Type: -

Identifier Source: org_study_id