Clinical trial NCT02938962: Intravenous vs. Topical Tranexamic Acid in Revision THA (VITALITY-X)
Official title: Revision Total Hip Arthroplasty: Comparison of the Effects of Intravenous and Topically Administered Tranexamic Acid in a Prospective Randomized Trial (VITALITY-X)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tranexamic Acid
Blood Loss, Surgical
Arthroplasty, Replacement, Hip
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate and compare the effects of intravenous and topical administration of tranexamic acid during revision hip arthroplasty on blood loss, allogenic blood transfusion rates, length of hospital stay and perioperative complications.

Detailed description: This study will use a prospective randomized single-blinded study design. The study will include one hundred and sixty patients undergoing revision total hip arthroplasty at a single institution (Mount Sinai Hospital (MSH), Toronto, ON, Canada). Tranexamic acid has been routinely administered as a single intravenous preoperative dose (unless contraindicated) in all revision hip arthroplasty cases at MSH since May 2012. In this study, participants will be randomized into 2 treatment groups: intravenous (IV) administration of tranexamic acid (TXA) and topical administration of TXA. The IV administration group will receive a single 20mg/kg dose of TXA prior to the skin incision. The topical administration group will have a 100mL solution (3g TXA in 100cc of normal saline) instilled into the surgical field during surgery. The primary outcome measured will be the delta hemoglobin (defined as the change in hemoglobin from preoperative measurement to POD 0, 1, 2, 3, 5). Secondary outcomes to be analyzed include intraoperative estimated blood loss, allogenic blood transfusion rates, length of hospital stay and postoperative complications.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years at the time of surgery.
* Consent for transfusion of blood or blood-related products.
* No contraindication to use of tranexamic acid.
* Revision hip arthroplasty performed at MSH.
* Indication for surgery including osteolysis, component failure, prosthetic joint infection, aseptic/septic loosening, periprosthetic fracture, recurrent instability/dislocation, polyethylene wear and abductor insufficiency.
* Revision hip arthroplasty procedure performed including acetabular component revision, femoral component revision, impaction bone grafting, proximal femoral allograft, proximal femoral replacement, removal of hardware (excluding head/liner exchanges).
* Direct lateral (transgluteal, Hardinge) approach utilized, including augmentation with extended trochanteric osteotomy (ETO), trochanteric slide and modified trochanteric slide.

Exclusion Criteria:

* Age \< 18 years at the time of surgery.
* Posterior (Moore, Southern) or Anterior (Smith-Peterson) operative approach utilized.
* Implantation of surgical drain.
* Patients undergoing any isolated combination of femoral head exchange, acetabular liner exchange and abductor repair.
* Patients with an absolute contraindication to tranexamic acid use including:
* Allergy to TXA or previous adverse reaction to TXA/its constituents.
* Thrombolytic events \<1 year prior to surgery (myocardial infarction, cerebrovascular accident, pulmonary embolus).
* Active thrombolytic event and/or on lifelong anticoagulant.
* Known coronary artery disease.
* Renal failure with serum creatinine \>200µmol/L, creatinine clearance \<50mL/min and/or dialysis patient.
* Patients with disseminated intravascular coagulation.
* Patients currently using Oral Contraceptive medication.
* Patients with a relative contraindication to tranexamic acid use deemed inappropriate for tranexamic acid administration by Anesthesiology team, including:
* Thrombolytic events \>1 year prior to surgery (myocardial infarction, cerebrovascular accident, pulmonary embolus).
* History of cancer.
* Patients with a history of acquired disturbances in color vision.
* Clinical judgment by Anesthesiology team not otherwise specified.
* Patients ineligible or refusing to consent for allogenic blood transfusion.
* Blood conservation augmentation strategies utilized:
* Cell saver/autotransfusion.
* Administration of erythropoietin.

Primary outcomes:
measure: Delta Hemoglobin
timeFrame: Post-operative day #0 to post-operative day #5
Secondary outcomes:
measure: Allogenic blood units transfused
timeFrame: through hospital admission, an average of 4 days
measure: Length of stay
timeFrame: through hospital admission, an average of 4 days
measure: Estimated intra-operative blood loss as assessed by the anaesthesiology team
timeFrame: Intra-operative
measure: Post-operative complications
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Paul Kuzyk, MD
role: PRINCIPAL_INVESTIGATOR
References: