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Effect of Early Administration of TXA in Adult Hip Fractures

ConditionPostoperative Blood Loss
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAscension Health

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Early Adminstration of TXA + Intraoperative TXAExperimental treatment 1 intervention
Group B: Intraoperative only TXAOther 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Blood Transfusion

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

Time frame
Up to two weeks
2

Overall Blood Loss

Calculate the difference in postoperative blood loss between groups

Time frame
Up to two weeks

Secondary outcomes

1

Length of hospital stay

Overall length of hospital stay

Time frame
Up to two weeks
2

Postoperative Pain

Difference in overall pain scores between groups

Time frame
Up to two weeks
3

Wound complications

Acute wound complications documented after surgical intervention

Time frame
Up to two weeks
4

Acute DVT/PE

Documented deep venous thrombosis or pulmonary embolism

Time frame
Up to two weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ascension Health

Lead sponsor

Source ClinicalTrials.gov
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