Using Tranexamic Acid to Reduce Blood Transfusions After Hip Fracture Surgery
Evaluating the Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion in Hip Fracture Patients
PHASE4 · ProMedica Health System · NCT03063892
This study tests whether giving Tranexamic Acid before, during, and after hip fracture surgery can help people over 60 need fewer blood transfusions.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | ProMedica Health System (other) |
| Locations | 1 site (Toledo, Ohio) |
| Trial ID | NCT03063892 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Tranexamic Acid (TXA), an antifibrinolytic medication, in reducing the need for blood transfusions in patients over 60 years old undergoing surgery for hip fractures. The study will administer TXA preoperatively, perioperatively, and postoperatively to assess its impact on blood loss and transfusion rates. By comparing TXA treatment with a saline solution, the trial aims to provide insights into its potential benefits for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients over the age of 60 who have sustained a hip fracture requiring surgical intervention.
Not a fit: Patients under the age of 60 or those with specific medical histories, such as recent myocardial infarction or known hypersensitivity to TXA, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for blood transfusions in elderly patients undergoing hip fracture surgery.
How similar studies have performed: While limited research exists on TXA use in hip fracture patients, other studies have shown its effectiveness in reducing blood transfusions in orthopedic surgeries, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over the age of 60 years * Hip fracture requiring surgical intervention * Signs consent and agrees to participate Exclusion Criteria: * Under the age of 60 * Does not sign consent or refuses participation * Known hypersensitivity to tranexamic acid * Multiple acute fractures * Creatinine clearance \<30 * History of seizures * Active hormone therapy * History of coagulation abnormality * History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last year or history or recurrent DVT/PE * Myocardial infarction (MI) and/or stents within the past year * History of intracranial hemorrhage * Acquired defective color vision * Patients admitted directly to nursing units or surgery without stay in the Emergency Center * Patients who sustain fracture while hospitalized at ProMedica Toledo Hospital
Where this trial is running
Toledo, Ohio
- ProMedica Toledo Hospital — Toledo, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Gregory M Georgiadis, MD — ProMedica Toledo Hospital
- Study coordinator: Kristin Gardner, MSN, RN
- Email: kristin.gardner@promedica.org
- Phone: 419-291-5927
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hip Fractures