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Intravenous Tranexamic Acid During Rhytidectomy

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ClinicalTrials.gov Identifier: NCT03970213
Recruitment Status : Not yet recruiting
First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Glasgold Group Plastic Surgery

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.

Condition or disease Intervention/treatment Phase
Bleeding Bruising Face Swelling Lips & Face Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml Drug: Normal Saline 0.9% Infusion Solution Bag Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Only the CRNA who is administering the medications is unmasked until completion of the data collection period.
Primary Purpose: Other
Official Title: Effects of Intravenous Tranexamic Acid During Rhytidectomy - a Randomized, Controlled, Double-blind Pilot Study
Estimated Study Start Date : May 30, 2019
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Intraoperative bleeding [ Time Frame: Surgical time ]
    Subjective measure of intraoperative blood loss (mild, moderate, or severe)

  2. Postoperative ecchymosis [ Time Frame: Postoperative day 1 ]
    Subjective measure of bruising rated as mild, moderate, or severe

  3. Postoperative ecchymosis [ Time Frame: Postoperative day 6 ]
    Subjective measure of bruising rated as mild, moderate, or severe

  4. Postoperative ecchymosis [ Time Frame: Postoperative day 9 ]
    Subjective measure of bruising rated as mild, moderate, or severe

  5. Postoperative edema [ Time Frame: Postoperative day 1 ]
    Subjective measure of swelling rated as mild, moderate, or severe

  6. Postoperative edema [ Time Frame: Postoperative day 6 ]
    Subjective measure of swelling rated as mild, moderate, or severe

  7. Postoperative edema [ Time Frame: Postoperative day 9 ]
    Subjective measure of swelling rated as mild, moderate, or severe


Secondary Outcome Measures :
  1. Postoperative hematoma/seroma [ Time Frame: 10 days postoperative ]
    Documentation of any postoperative collections seen during the first 10 days following surgery

  2. Complications [ Time Frame: 10 days postoperative ]
    Documentation of any surgical or postoperative complications



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970213


Contacts
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Contact: Mark J Glasgold, MD 732-846-6540 mglasgold@gmail.com
Contact: Justin C Cohen, MD 732-846-6540 justinccohen@gmail.com

Locations
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United States, New Jersey
Glasgold Group Plastic Surgery Recruiting
Princeton, New Jersey, United States, 08540
Contact: Mark J Glasgold, MD    732-846-6540    mglasgold@gmail.com   
Sub-Investigator: Robert A Glasgold, MD         
Sponsors and Collaborators
Glasgold Group Plastic Surgery
Investigators
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Study Director: Mark J Glasgold, MD Glasgold Group Plastic Surgery

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Responsible Party: Glasgold Group Plastic Surgery
ClinicalTrials.gov Identifier: NCT03970213     History of Changes
Other Study ID Numbers: GGPS19-01
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient demographics, surgical procedure performed, primary and secondary outcomes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Will be made available via publication

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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

Keywords provided by Glasgold Group Plastic Surgery:
Tranexamic acid
Rhytidectomy
Facelift

Additional relevant MeSH terms:
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Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants