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Effect of Early Administration of TXA in Adult Hip Fractures

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

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05047133
Enrollment
170
Registered
2021-09-16
Start date
2021-09-01
Completion date
2022-07-01
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Blood Loss

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.

Interventions

DRUGTranexamic 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

Sponsors

Ascension Health
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Blood TransfusionUp to two weeksPatient receives a blood transfusion during their postoperative stay in the hospital
Overall Blood LossUp to two weeksCalculate the difference in postoperative blood loss between groups

Secondary

MeasureTime frameDescription
Length of hospital stayUp to two weeksOverall length of hospital stay
Postoperative PainUp to two weeksDifference in overall pain scores between groups
Wound complicationsUp to two weeksAcute wound complications documented after surgical intervention
Acute DVT/PEUp to two weeksDocumented deep venous thrombosis or pulmonary embolism

Countries

United States

Contacts

Primary ContactJacob Hinkley, DO, MS
jacob.hinkley2@ascension.org810-606-5669
Backup ContactJacob Lytle, DO
jacob.lytle@ascension.org810-606-5669

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026