Tranexamic Acid in Revision Total Joint Arthroplasty
1 other identifier
interventional
175
1 country
3
Brief Summary
To determine the optimal dosing regimen and route of administration of tranexamic acid (TXA) \[single dose intravenous (IV), double dose intravenous, intravenous + topical, and oral repeated dosing\] to minimize post-operative blood loss and transfusion requirements following revision total knee arthroplasty (RTKA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2016
Typical duration for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 14, 2016
CompletedFirst Posted
Study publicly available on registry
August 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedApril 22, 2021
April 1, 2021
3.3 years
April 14, 2016
April 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Post-operative reduction in Hemoglobin
Pre-operative hemoglobin minus the lowest post-operative hemoglobin prior to any transfusion
Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Post-operative reduction in Hematocrit
Pre-operative hematocrit minus the lowest post-operative hematocrit prior to any transfusion
Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Calculated blood loss
Based on predicted blood volume and hemoglobin balance
Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Number of units transfused
per patient
Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Number of Patients Transfused
Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Secondary Outcomes (4)
Cost-comparison
Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Deep Vein Thrombosis, Pulmonary Embolus, Cerebrovascular accident or Transient ischemic attack
Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Return to the OR within 30 days; Re-admission within 30 days; Periprosthetic fracture within 30 days
Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Superficial infection or Deep infection, defined as Synovial White Blood Cell (WBC) count > 4200 WBC/ml or Synovial WBC > 3000 WBC/ml & C-Reactive Protein (CRP) > 10 mg/dl & Erythrocyte Sedimentation Rate (ESR) > 30 mm/hr ;
Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Study Arms (4)
Single IV Dose
ACTIVE COMPARATOR• 1 gram IV TXA administered at time of prepping and draping
Double Dose IV
ACTIVE COMPARATOR* 1 gram IV TXA administered at time of prepping and draping * 1 gram IV TXA administered prior to tourniquet deflation
IV + Topical
ACTIVE COMPARATOR* 1 gram IV TXA administered at time of prepping and draping * 1 gram topical TXA injected intra-articular following closure of the arthrotomy
Repeated Oral Dose
ACTIVE COMPARATOR• Three 650 mg tablets of TXA administered two hours prior surgery with a second dose given 6 hours postoperatively and a final dose given the morning of postoperative day 1
Interventions
Femoral component exchange, tibial component exchange, both component exchange, explant of both components and placement of antibiotic cement spacer, or a second stage re-implantation procedure. Given the variability in blood loss between types of revision TKA, randomization will be done to ensure equivalent numbers of each type of revision TKA between the treatment groups.
Femoral component exchange, acetabulum component exchange, both component exchange, explant of both components and placement of antibiotic cement spacer, or a second stage re-implantation procedure. Given the variability in blood loss between types of revision THA, randomization will be done to ensure equivalent numbers of each type of revision THA between the treatment groups.
Eligibility Criteria
You may qualify if:
- Patients scheduled for revision THA or TKA defined as femoral component exchange, acetabulum/tibial component exchange, both component exchange, explant of both components and placement of antibiotic cement spacer, or a second stage re-implantation procedure.
You may not qualify if:
- Patients scheduled for a head and liner/poly exchange, known allergy to TXA, acquired disturbances of color vision, refusal of blood products, pre-operative use of anticoagulant therapy within five days before surgery, a history of arterial or venous thrombotic disease (including a history of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA)), pregnancy, breastfeeding, or major co-morbidities (myocardial infarction or stent placement within one year, severe pulmonary disease, renal impairment, or hepatic failure).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rush University Medical Centerlead
- Mayo Cliniccollaborator
Study Sites (3)
Rush University Medical Center
Chicago, Illinois, 60612, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
New York University Medical Center
New York, New York, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Craig J Della Valle, MD
Rush University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Adult Reconstruction
Study Record Dates
First Submitted
April 14, 2016
First Posted
August 24, 2016
Study Start
April 1, 2016
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
April 22, 2021
Record last verified: 2021-04