Recruiting

Tranexamic Acid vs. Tranexamic Acid

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT02938962

Conditions

Tranexamic Acid

Blood Loss, Surgical

Arthroplasty, Replacement, Hip

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Tranexamic Acid

Study Details

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.

Conditions

Tranexamic Acid

Blood Loss, Surgical

Arthroplasty, Replacement, Hip

Study ID

NCT02938962

Start date

Oct, 2016

Status verified date

Oct, 2016

Primary completion date

Nov, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Intravenous TXA

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

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.

Interventions

Tranexamic Acid

Primary outcome measure

  • Delta Hemoglobin [ Time Frame: Post-operative day #0 to post-operative day #5 ]

Central Contacts and Locations

Central contacts

Paul Kuzyk, MD

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

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G1X5

Contacts

Paul Kuzyk, MD, MSc

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

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Oct 19, 2016

Last verified

Oct, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2016-10-19.