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

Arthroplasty, Replacement, Hip Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02938962
• Other study ID #: 16-0046-A
• Status: Recruiting
• Phase: Phase 4
• First received: October 3, 2016
• Last updated: October 18, 2016
• Start date: October 2016

Study information

• Verified date: October 2016
• Source: Mount Sinai Hospital, Canada
• Contact: Paul Kuzyk, MD
• Phone: 416-586-4653
• Email: pkuzyk[@]mtsinai.on.ca
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Blood Loss, Surgical
• Tranexamic Acid

Intervention

Drug:
• Tranexamic Acid

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Allogenic blood units transfused		through hospital admission, an average of 4 days	Yes
Secondary	Length of stay		through hospital admission, an average of 4 days	No
Secondary	Estimated intra-operative blood loss as assessed by the anaesthesiology team		Intra-operative	Yes
Secondary	Post-operative complications		3 months postoperatively	Yes