Effect of Early Administration of TXA in Adult Hip Fractures

Ascension Genesys Hospital

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Postoperative Blood Loss

Treatments: Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05047133

1722787-1

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Early Adminstration of TXA + Intraoperative TXA

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic acid

Intraoperative only TXA

Other group

Description:

This group will only receive the intraoperative TXA.

Treatment:

Drug: Tranexamic acid