NCT02993341

Brief Summary

Mechanisms by which to reduce exposure to allogeneic blood are of financial and clinical benefit in the hip fracture population. Tranexamic acid (TXA) is an inexpensive medication with low complication risk. Its use in the hip fracture population is unproven. The purpose of this study is to evaluate the efficacy and safety of topical tranexamic acid in reduction of peri-operative blood loss in hip fracture surgery.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2019

Completed
Last Updated

August 19, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

April 12, 2016

Last Update Submit

August 15, 2019

Conditions

Hip FractureAnemia

Outcome Measures

Primary Outcomes (1)

  • Change in hemoglobin

    change in hemoglobin levels day 1 and 3 post-op compared to pre-op values and need for allogenic blood transfusion up to 3 days post-op

    1 day and 3 days post-surgery

Secondary Outcomes (3)

  • All-cause mortality

    30 days post-surgery

  • Reduced risk of thrombotic event

    30 days post-surgery

  • Reduced peri-operative complications

    30 days post-surgery

Study Arms (2)

Tranexamic Acid Wash

EXPERIMENTAL

Participants in the experimental arm will receive a wash of tranexamic acid topically at the site of surgery.

Drug: Tranexamic Acid

Saline Wash

PLACEBO COMPARATOR

Participants in the control arm will receive a wash of saline topically at the site of surgery.

Other: Saline Wash

Interventions

Tranexamic AcidDRUG
Tranexamic Acid Wash
Saline WashOTHER
Saline Wash

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All of the following criteria must be met to be eligible:
  • years of age or older
  • Diagnosis of hip fracture (Intracapsular, Intratrochanteric or Subtrochanteric) requiring surgical repair
  • Patient/surrogate decision maker provide signed informed consent

You may not qualify if:

  • Participants cannot be included in this study if any of the following criteria apply:
  • Patient has documented renal failure with glomerular filtration rate of \<30ml/min/1.73m2
  • Documented allergy to tranexamic acid
  • Current use of hormone replacement therapy
  • Acquired disturbances of colour vision
  • Refusal of blood products
  • Pre-operative use of anticoagulant therapy (Coumadin, heparin \< 5 days of surgery, fibrinolytic disorders requiring intraoperative anti-fibrinolytic treatment)
  • Coagulopathy (pre-operative platelet count \<150,000/mm3, International Normalized Ratio (INR) \>1.4, prolonged Partial Thromboplastin Time (PTT) \>1.4x normal)
  • Hematuria
  • Acute coronary syndrome within 6 weeks of fracture
  • Any history of venous thromboembolism
  • Any intraoperative surgical/medical/anesthetic complications i.e.: myocardial infarction or neurovascular injury occurring prior to application of the tranexamic acid
  • Pregnant or lactating
  • Any major medical or psychiatric disorder that in the opinion of the investigator, might prevent the subject from completely participating in the study or interfere with the interpretation of the study results
  • Unable/unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sault Area Hospital

Sault Ste. Marie, Ontario, P6B0A8, Canada

Location

Related Publications (1)

  • Costain D, Elder G, Fraser B, Slagel B, Kelly A, Cheong Y, Fera L. Topical tranexamic acid in hip fractures: a randomized, placebo-controlled double-blinded study. Can J Surg. 2021 Aug 10;64(4):E449-E456. doi: 10.1503/cjs.014220. Epub 2021 Aug 1.

    PMID: 34388107DERIVED

MeSH Terms

Conditions

Hip FracturesAnemia

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2016

First Posted

December 15, 2016

Study Start

November 1, 2016

Primary Completion

March 5, 2019

Last Updated

August 19, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)