NCT02938962

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

2.1 years

First QC Date

October 3, 2016

Last Update Submit

October 18, 2016

Conditions

Tranexamic AcidBlood Loss, SurgicalArthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (1)

  • Delta Hemoglobin

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

    Post-operative day #0 to post-operative day #5

Secondary Outcomes (4)

  • Allogenic blood units transfused

    through hospital admission, an average of 4 days

  • Length of stay

    through hospital admission, an average of 4 days

  • Estimated intra-operative blood loss as assessed by the anaesthesiology team

    Intra-operative

  • Post-operative complications

    3 months postoperatively

Study Arms (2)

Intravenous TXA

ACTIVE COMPARATOR

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

Drug: Tranexamic Acid

Topical TXA

ACTIVE COMPARATOR

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

Interventions

Tranexamic AcidDRUG
Intravenous TXATopical TXA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

RECRUITING

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Paul Kuzyk, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Kuzyk, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 19, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2018

Last Updated

October 19, 2016

Record last verified: 2016-10

Locations

CA(1)