Phase 4 N=127 Randomized Double-blind Treatment

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

Blood Loss

Bottom Line

View on ClinicalTrials.gov: NCT02374398 ↗

Enrolled (actual)

127

Serious AEs

0.0%

Results posted

Jan 2017

Primary outcome: Primary: The Change in Hemoglobin (Hb) From the Day of Surgery — 2.6; 3.2; 2.6; 3.7 g/dl

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tranexamic Acid (Drug); Aquamantys System (Device); Control (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eastern Maine Medical Center
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY The Change in Hemoglobin (Hb) From the Day of Surgery	2.6; 3.2; 2.6; 3.7	—
PRIMARY The Change in Hematocrit (Ht) From the Day of Surgery	7.1; 8.6; 6.8; 10.0	—
SECONDARY Post Operative Blood Loss	747.9; 938.9; 746.6; 1077.6	—
SECONDARY Cost Analysis	NA; NA; NA; NA	—
SECONDARY Adverse Events	0; 0; 0; 0	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02374398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.