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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eastern Maine Medical Center
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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