Effect of Early Administration of TXA in Adult Hip Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-07-01

Brief Summary

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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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Detailed Description

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Conditions

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Postoperative Blood Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type 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

Intraoperative only TXA

This group will only receive the intraoperative TXA.

Group Type OTHER

Tranexamic acid

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Lysteda

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes