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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mount Sinai Hospital, Canada
• Treatments: Tranexamic Acid

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.