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Recruiting NCT05047133

Effect of Early Administration of TXA in Adult Hip Fractures

Phase II / Phase III Interventional Postoperative Blood Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tranexamic acid.
Who it may be relevant to
Registry conditions: Postoperative Blood Loss. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Does Early Administration of Tranexamic Acid Decrease Perioperative Blood Loss in Addition to Intraoperative Tranexamic Acid for Hip Fracture Patients?

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Postoperative Blood Transfusion [Time frame: Up to two weeks]
  • Overall Blood Loss [Time frame: Up to two weeks]
Secondary outcome measures (4)
  • Length of hospital stay [Time frame: Up to two weeks]
  • Postoperative Pain [Time frame: Up to two weeks]
  • Wound complications [Time frame: Up to two weeks]
  • Acute DVT/PE [Time frame: Up to two weeks]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Ascension Genesys Hospital — Grand Blanc

Identifiers

NCT: NCT05047133 · 1722787-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗