Effect of Early Administration of TXA in Adult Hip Fractures

Phase 2

Recruiting

• Conditions: Postoperative Blood Loss
• Interventions: Drug: Tranexamic acid

• Registration Number: NCT05047133
• Lead Sponsor: Ascension Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study Start: 2021-09-01
• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-14
• Last Update Submitted: 2021-09-14
• Study First Posted: 2021-09-16
• Last Update Posted: 2021-09-16
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Adminstration of TXA + Intraoperative TXA	Tranexamic acid	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.
Intraoperative only TXA	Tranexamic acid	This group will only receive the intraoperative TXA.

Primary Outcome Measures

Name	Time	Method
Postoperative Blood Transfusion	Up to two weeks	Patient receives a blood transfusion during their postoperative stay in the hospital
Overall Blood Loss	Up to two weeks	Calculate the difference in postoperative blood loss between groups

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	Up to two weeks	Overall length of hospital stay
Postoperative Pain	Up to two weeks	Difference in overall pain scores between groups
Wound complications	Up to two weeks	Acute wound complications documented after surgical intervention
Acute DVT/PE	Up to two weeks	Documented deep venous thrombosis or pulmonary embolism

Trial Locations

Locations (1)

Ascension Genesys Hospital; 🇺🇸 Grand Blanc, Michigan, United States