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NCT Number: NCT05047133

Effect of Early Administration of TXA in Adult Hip Fractures

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.

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Key information

Conditions

Postoperative Blood Loss Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ascension Genesys Hospital

Grand Blanc, Michigan, 48439, United States

Location status: Recruiting

Location contact

Sandra Watt, MS, BSN

CONTACT

[email protected]

810-606-7713

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tranexamic Acid

Drug

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

Primary outcomes

  1. Postoperative Blood Transfusion

    Time frame: Up to two weeks

    Patient receives a blood transfusion during their postoperative stay in the hospital

  2. Overall Blood Loss

    Time frame: Up to two weeks

    Calculate the difference in postoperative blood loss between groups

Secondary outcomes

  1. Length of hospital stay

    Time frame: Up to two weeks

    Overall length of hospital stay

  2. Postoperative Pain

    Time frame: Up to two weeks

    Difference in overall pain scores between groups

  3. Wound complications

    Time frame: Up to two weeks

    Acute wound complications documented after surgical intervention

  4. Acute DVT/PE

    Time frame: Up to two weeks

    Documented deep venous thrombosis or pulmonary embolism

Study contacts

Contact information is provided by the study sponsor or research team.

Jacob Hinkley, DO, MS

CONTACT

[email protected]

810-606-5669

Jacob Lytle, DO

CONTACT

[email protected]

810-606-5669

Sponsors and collaborators

Lead sponsor

Ascension Health

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2021
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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