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

Revision Total Hip Arthroplasty: Comparison of the Effects of Intravenous and Topically Administered Tranexamic Acid in a Prospective Randomized Trial (VITALITY-X)

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.

Study Overview

• Status: Unknown
• Conditions: Blood Loss, Surgical; Arthroplasty, Replacement, Hip; Tranexamic Acid
• Intervention / Treatment: Drug: Tranexamic Acid

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Paul Kuzyk, MD, MSc; Phone Number: (416) 586-4653; Email: pkuzyk@mtsinai.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous TXA; The IV administration group will receive a single 20mg/kg dose of TXA prior to the skin incision.	Drug: Tranexamic Acid
Active Comparator: Topical TXA; The topical administration group will have a 100mL solution (3g TXA in 100cc of normal saline) instilled into the surgical field throughout the operative procedure; 50mL of the solution will be instilled after bony preparation of the acetabulum and/or femur and 50mL of the solution will be instilled prior to closure. The topical TXA solution will be allowed to bathe the wound for 5 minutes at each administration.	Drug: Tranexamic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delta Hemoglobin	Delta hemoglobin (defined as the change in hemoglobin from preoperative measurement to post-operative day 0, 1, 2, 3, 5).	Post-operative day #0 to post-operative day #5

Secondary Outcome Measures

Outcome Measure	Time Frame
Allogenic blood units transfused	through hospital admission, an average of 4 days
Length of stay	through hospital admission, an average of 4 days
Estimated intra-operative blood loss as assessed by the anaesthesiology team	Intra-operative
Post-operative complications	3 months postoperatively

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Investigators: Principal Investigator: Paul Kuzyk, MD, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: October 3, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 16-0046-A