Clinical trial NCT01940523: Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical
Official title: Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: total knee arthroplasty
total knee replacement
tranexamic acid
osteoarthritis
degenerative joint disease
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2013-09-12
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether topical or intravenous administration of tranexamic acid during unilateral total knee replacement is more effective at reducing bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that has been shown to reduce blood drain output and the need for blood transfusions in both its topical and intravenous forms and is commonly used in orthopedic surgery. We hypothesize that IV and topical administration of tranexamic acid will be equally good at reducing the loss of blood and the need for transfusion immediately following total knee replacement.

Detailed description: This randomized controlled trial compares the blood loss of patients undergoing unilateral total knee replacements who randomly receive either the topical or the intravenous form of tranexmamic acid during surgery. Patients in the intravenous arm of the study will receive 1 gram of tranexamic acid in 10 milliliters of solution prior to inflation of the tourniquet and 1 gram of tranexamic acid in 10 milliliters of solution during closure. For patients in the topical arm of the study, prior to the release of the tourniquet they will receive 3 grams of tranexamic acid in 75ccs of solution directly on the site of the incision.

The primary result measurement will be blood drain output from the knee at 24 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* Primary total knee replacmeent
* Osteoarthritis
* Unilateral

Exclusion Criteria:

* Revision surgery
* Donated preoperative autologous blood
* On chronic anticoagulation medication such as Coumadin, Xarelto, Plavix, or Aspirin (other than 81mg)
* Preoperative hepatic or renal dysfunction
* Diagnosis of inflammatory disease
* Diagnosis of inflammatory arthritis
* Pregnant
* Breastfeeding
* Preoperative hemoglobin \<10g/dL
* International Normalized Ratio\>1.4
* Abnormal Partial Thromboplastin Time
* Preoperative platelet count of \<150,000mm\^3
* Creatinine \> 1.4

Primary outcomes:
measure: Total Blood Loss
timeFrame: during surgery
Secondary outcomes:
measure: Drain Output
timeFrame: from end of surgery to 24 hours postoperatively
measure: The Number Patients Requiring a Transfusion
timeFrame: over course of hospital stay (averaging three days)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: David Mayman, MD
role: PRINCIPAL_INVESTIGATOR
References: