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

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ClinicalTrials.gov Identifier: NCT02938962
Recruitment Status : Unknown
Verified October 2016 by Mount Sinai Hospital, Canada.
Recruitment status was:  Recruiting
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

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.

Condition or disease Intervention/treatment Phase
Tranexamic Acid Blood Loss, Surgical Arthroplasty, Replacement, Hip Drug: Tranexamic Acid Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Revision Total Hip Arthroplasty: Comparison of the Effects of Intravenous and Topically Administered Tranexamic Acid in a Prospective Randomized Trial (VITALITY-X)
Study Start Date : October 2016
Estimated Primary Completion Date : November 2018

Resource links provided by the National Library of Medicine


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



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


Secondary Outcome Measures :
  1. Allogenic blood units transfused [ Time Frame: through hospital admission, an average of 4 days ]
  2. Length of stay [ Time Frame: through hospital admission, an average of 4 days ]
  3. Estimated intra-operative blood loss as assessed by the anaesthesiology team [ Time Frame: Intra-operative ]
  4. Post-operative complications [ Time Frame: 3 months postoperatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938962


Contacts
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Contact: Paul Kuzyk, MD 416-586-4653 pkuzyk@mtsinai.on.ca

Locations
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Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G1X5
Contact: Paul Kuzyk, MD, MSc    (416) 586-4653    pkuzyk@mtsinai.on.ca   
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
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Principal Investigator: Paul Kuzyk, MD MOUNT SINAI HOSPITAL

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Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT02938962     History of Changes
Other Study ID Numbers: 16-0046-A
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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Blood Loss, Surgical
Hemorrhage
Pathologic Processes
Intraoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants