Phase 2 N=101 Randomized Triple-blind Treatment

Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty

Acute Blood Loss Anemia · Osteoarthritis, Knee

Bottom Line

View on ClinicalTrials.gov: NCT01370460 ↗

Enrolled (actual)

101

Serious AEs

—

Results posted

Jul 2013

Primary outcome: Primary: Blood Loss — 1293.1; 940.2 mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Tranexamic Acid (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Henry Ford Health System
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Blood Loss	1293.1; 940.2	—
SECONDARY Postoperative Transfusion Rate	0; 4	—

Summary

This study aims to assess postoperative blood loss and transfusion rates in total knee replacement after one-time administration of topical tranexamic acid.

Eligibility Criteria

Inclusion Criteria

All adult patients over age eighteen
Primary unilateral total knee arthroplasty at Henry Ford Hospital (Detroit, Michigan, United States) and Henry Ford West Bloomfield Hospital (West Bloomfield, Michigan, United States)

Exclusion Criteria

patient history of venous thromboembolic disease or coagulopathy
use of anticoagulant medications within 7 days of surgery
history of arterial embolic disease
history of Class III or IV heart failure
renal failure
intraoperative cardiovascular, pulmonary, orthopaedic, or anesthetic complication (MI, intraoperative fracture, vasopressor support, emergent intubation).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01370460). 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.