NCT01714336

Brief Summary

Does tranexamic acid improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2012

Typical duration for phase_4

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

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
8 months until next milestone

Results Posted

Study results publicly available

May 16, 2016

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

3.1 years

First QC Date

October 23, 2012

Results QC Date

April 8, 2016

Last Update Submit

November 12, 2018

Conditions

Hip Fracture

Keywords

Arbeitsgemeinschaft für Osteosynthesefragen (AO) fractureOrthopaedic Trauma Association (OTA) fracture

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Received a Hospitalization Transfusion

    Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission

    5 days

Secondary Outcomes (7)

  • Mean Number of Units Transfused

    5 days

  • Calculated Blood Loss

    5 days

  • Number of Participants With Venous Thromboembolism (VTE) Diagnosis

    Within 6 months of surgery

  • Number of Participants With Wound Complications

    Within 6 months of surgery

  • Number of Participants With Myocardial Infarction (MI) Diagnosis

    Within 6 months of surgery

  • +2 more secondary outcomes

Study Arms (2)

placebo

PLACEBO COMPARATOR

Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.

Drug: placebo

tranexamic acid

ACTIVE COMPARATOR

Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.

Drug: tranexamic acid

Interventions

tranexamic acidDRUG

Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.

tranexamic acid
placeboDRUG

A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.

placebo

Eligibility Criteria

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

You may qualify if:

  • AO/OTA (Orthopedic Trauma Association) fracture classification 31B
  • Surgically treated with either hemiarthroplasty or total hip arthroplasty
  • Acute fracture treated within 72 hours of injury
  • Low energy isolated injury
  • Age greater than 18 years old

You may not qualify if:

  • Transfusion received during admission, prior to surgery
  • Creatinine clearance less than 30 mL/min
  • History of unprovoked Venous Thromboembolism (VTE) and/or recurrent VTE
  • Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
  • Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential)
  • History of cerebrovascular accident (CVA), Myocardial infarction (MI), or VTE within the previous 30 days
  • Coronary stent placement within the previous 6 months
  • Disseminated intravascular coagulation
  • Subarachnoid hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hip FracturesFractures, Bone

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Femoral FracturesWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Dr. Mark Pagnano
Organization
Mayo Clinic
pagnano.mark@mayo.edu
507-284-2511

Study Officials

  • Mark Pagnano, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 23, 2012

First Posted

October 25, 2012

Study Start

September 1, 2012

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 14, 2018

Results First Posted

May 16, 2016

Record last verified: 2018-11

Locations

US(1)