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Antifibrinolytic Agent
TXA in the Reduction of Post-Op Hematoma and Seroma in Patients Undergoing Panniculectomy or Abdominoplasty
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
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial is testing if a medication can reduce bleeding in patients having excess abdominal skin removed. The medication helps blood to clot, which may lead to less bleeding during and after surgery. It has been widely used to reduce blood loss in various surgical procedures, including aesthetic plastic surgery, hip replacement, and gynecologic 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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Participants With Post Operative Hematoma
Post Surgical Drain Output in CCs
Secondary study objectives
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
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
1,474 Total Patients Enrolled
Amir Behnam, MDPrincipal InvestigatorReading Hospital