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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

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 below

Timeline

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to eight weeks post-operatively for reporting.

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 • NCT00740116

22%

Readmissions

14%

Postoperative infections

10%

Re-operations

Thromboembolic events

100%

80%

60%

40%

20%

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

0 / 1Eligibility criteria met