Intravenous vs. Topical Tranexamic Acid in Revision THA (VITALITY-X)

Mount Sinai Hospital, Canada160 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

160

Conditions

Tranexamic Acid Blood Loss, Surgical Arthroplasty, Replacement, Hip

Interventions

Tranexamic AcidDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Mount Sinai Hospital

Toronto, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

Delta Hemoglobin

Delta hemoglobin (defined as the change in hemoglobin from preoperative measurement to post-operative day 0, 1, 2, 3, 5).

Time frame: Post-operative day #0 to post-operative day #5

Secondary Outcomes

Allogenic blood units transfused

Time frame: through hospital admission, an average of 4 days

Length of stay

Time frame: through hospital admission, an average of 4 days

Estimated intra-operative blood loss as assessed by the anaesthesiology team

Time frame: Intra-operative

Post-operative complications

Time frame: 3 months postoperatively

Central Contacts

Paul Kuzyk, MD

CONTACT

416-586-4653 pkuzyk@mtsinai.on.ca

Data from ClinicalTrials.gov

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