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

NCT ID: NCT02938962

Last Updated: 2016-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Intravenous TXA

The IV administration group will receive a single 20mg/kg dose of TXA prior to the skin incision.

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

Interventions

Tranexamic Acid

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Kuzyk, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Paul Kuzyk, MD

Role: CONTACT

pkuzyk@mtsinai.on.ca

416-586-4653

Facility Contacts

Paul Kuzyk, MD, MSc

Role: primary

pkuzyk@mtsinai.on.ca

(416) 586-4653

Other Identifiers

16-0046-A

Identifier Type: -

Identifier Source: org_study_id