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

Primary Purpose

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

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tranexamic Acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mount Sinai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intravenous TXA

Topical TXA

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Delta Hemoglobin
Delta hemoglobin (defined as the change in hemoglobin from preoperative measurement to post-operative day 0, 1, 2, 3, 5).

Secondary Outcome Measures

Allogenic blood units transfused
Length of stay
Estimated intra-operative blood loss as assessed by the anaesthesiology team
Post-operative complications

Full Information

First Posted
October 3, 2016
Last Updated
October 18, 2016
Sponsor
Mount Sinai Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02938962
Brief Title
Intravenous vs. Topical Tranexamic Acid in Revision THA (VITALITY-X)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Sinai Hospital, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tranexamic Acid, Blood Loss, Surgical, Arthroplasty, Replacement, Hip

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous TXA
Arm Type
Active Comparator
Arm Description
The IV administration group will receive a single 20mg/kg dose of TXA prior to the skin incision.
Arm Title
Topical TXA
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Primary Outcome Measure Information:
Title
Delta Hemoglobin
Description
Delta hemoglobin (defined as the change in hemoglobin from preoperative measurement to post-operative day 0, 1, 2, 3, 5).
Time Frame
Post-operative day #0 to post-operative day #5
Secondary Outcome Measure Information:
Title
Allogenic blood units transfused
Time Frame
through hospital admission, an average of 4 days
Title
Length of stay
Time Frame
through hospital admission, an average of 4 days
Title
Estimated intra-operative blood loss as assessed by the anaesthesiology team
Time Frame
Intra-operative
Title
Post-operative complications
Time Frame
3 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Kuzyk, MD
Phone
416-586-4653
Email
pkuzyk@mtsinai.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Kuzyk, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Kuzyk, MD, MSc
Phone
(416) 586-4653
Email
pkuzyk@mtsinai.on.ca

12. IPD Sharing Statement

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

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