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Antifibrinolytic Agent
Tranexamic acid for Panniculectomy
Phase 4
Waitlist Available
Led By Amir Behnam, MD
Research Sponsored by The Reading Hospital and Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
• Patients undergoing panniculectomy or abdominoplasty.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 56 days post operatively.
Awards & highlights
Study Summary
This trial is testing whether the use of tranexamic acid (TXA) can decrease bleeding and fluid collections in patients undergoing panniculectomy, which is the removal of excess lower abdominal skin and soft tissue. TXA is a medication that is currently used in many surgical subspecialties to control bleeding, but its use in this study is experimental. The results of this study will help the researchers determine if TXA is effective in decreasing blood loss following surgery.
Eligible Conditions
- Panniculectomy
- Tummy Tuck
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to eight weeks post-operatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to eight weeks post-operatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Participants With Post Operative Hematoma
Post Surgical Drain Output in CCs
Secondary outcome measures
Number of Days Until Drain Removal
Number of Participants That Returned to the Operating Room
Side effects data
From 2012 Phase 4 trial • 100 Patients • NCT0074011622%
Readmissions
14%
Postoperative infections
10%
Re-operations
4%
Thromboembolic events
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Group
Tranexamic Group
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 2Experimental Treatment1 Intervention
The solution of Tranexamic Acid (TXA) will be placed into a sterile bowl in the operating area and three lap sponges will be placed in the solution at the beginning of the procedure. Group 2 will undergo application of three (TXA) soaked lap sponges to the surgical site. The lap sponges will be removed after three minutes and measurements will be taken for the study.
Group II: Group 1Placebo Group1 Intervention
The solution of saline will be placed into a sterile bowl in the operating area and three lap sponges will be placed in the solution at the beginning of the procedure. Group 1 will undergo application of three normal saline soaked lap sponges to the surgical site. The lap sponges will be removed after three minutes and measurements will be taken for the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
FDA approved
Find a Location
Who is running the clinical trial?
The Reading Hospital and Medical CenterLead Sponsor
13 Previous Clinical Trials
1,527 Total Patients Enrolled
Amir Behnam, MDPrincipal InvestigatorReading Hospital
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
British Columbia
How old are they?
18 - 65
What site did they apply to?
Reading Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Trying to find a clinical trial for abdominoplasty and/or breast augmentation (lift).
PatientReceived 2+ prior treatments
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