Print

Purpose

This is a prospective clinical study designed to assess blood loss in intracapsular and extracapsular hip fractures undergoing operative fixation at a Level II trauma center. It is well established in the orthopedic literature that tranexamic acid (TXA) decreases blood loss and need for postoperative blood transfusion in hip fracture patients as well as total joint arthroplasty patients. A typical dosing pattern, and the dosing pattern employed at our institution, is 1 gram IV infused prior to incision followed by 1 gram IV infused at the time of wound closure.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 1. All adult (18 years old or older) hip fracture patients presenting with an acute hip fracture and undergoing operative fixation

Exclusion Criteria

  1. Polytrauma patients 2. Previous operation on the ipsilateral hip 3. Patients with coagulopathies (Factor V Leiden, Sickle Cell Anemia, Etc.) 4. Patients with < 6-month history of thromboembolic event (DVT/PE), Stroke, Cardiac Stents, or Myocardial Infarction (MI) 5. History of seizure disorder 6. Patients on birth control 7. Pregnant Women 8. Prisoners 9. Active thromboembolic disease (DVT/PE, MI, Stroke)

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Early Adminstration of TXA + Intraoperative TXA 		This group receives 1 G of TXA as soon as possible after a diagnosis of an acute hip fracture if the patient meets inclusion and exclusion criteria. The group will also receive 2 grams of TXA total intraoperatively.
  • Drug: Tranexamic acid
    TXA to be given at time of diagnosis in the emergency department (ED) in treatment group and at time of operation for both groups
    Other names:
    • Lysteda
Other
Intraoperative only TXA 		This group will only receive the intraoperative TXA.
  • Drug: Tranexamic acid
    TXA to be given at time of diagnosis in the emergency department (ED) in treatment group and at time of operation for both groups
    Other names:
    • Lysteda

Recruiting Locations

Ascension Genesys Hospital
Grand Blanc, Michigan 48439
Contact:
Sandra Watt, MS, BSN
810-606-7713
sandra.watt@ascension.org

More Details

Status
Recruiting
Sponsor
Ascension Health

Study Contact

Jacob Hinkley, DO, MS
810-606-5669
jacob.hinkley2@ascension.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.