Clinical Trial Comparing Tranexamic Acid (TXA) With Aquamantys Sealer in Total Knee Arthroplasty (TKA)

Completed · Phase 4 · Has a placebo group

Conditions studied: Blood Loss

In brief

The aim of the study is to determine if the use of iv TXA or Aquamantys system improve the postoperative hemoglobin and hematocrit after primary TKA and what is the effect of the simultaneous use of iv TXA and Aquamantys on the postoperative hemoglobin and hematocrit. The assumption is that the combination of iv TXA and Aquamantys system will enable an improvement in the postoperative hemoglobin and hematocrit equal or larger than the improvement generated by the use of Aquamantys system alone.

Key facts

Study ID

NCT02374398

Run by

Eastern Maine Medical Center

People needed

127

Starts

2011-03-01

Expected to finish

2014-11-01

Last updated by the study team

2017-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult patients over age of 18 undergoing elective total primary knee arthroplasty under spinal anesthesia.

You may not qualify if…

• Previous adverse reaction to tranexamic acid
• Congenital or acquired coagulation disorders
• Preoperative platelet count of less than 100,000/microliter or INR> 1.4
• History of deep venous thrombosis, pulmonary embolism or cerebrovascular accident
• Patients with acquired defective color vision
• Renal insufficiency (Glomerular filtration rate <20 ml/min)
• Severe liver disease
• Coronary stents
• Pregnant patients
• Main anesthetic other than spinal anesthesia

Where it is running

• Eastern Maine Medical Center — Bangor, Maine, United States

Full record on ClinicalTrials.gov

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