Actively Recruiting
Effect of Early Tranexamic Acid Administration on Perioperative Blood Loss in Adult Hip Fracture Patients Undergoing Surgery
Led by Ascension Health · Updated on 2021-09-16
170
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of early administration of tranexamic acid (TXA) on blood loss in adults with intracapsular and extracapsular hip fractures undergoing surgery. The study aims to assess whether giving TXA as soon as possible after diagnosis, in addition to the usual intraoperative dose, reduces perioperative blood loss and the need for postoperative blood transfusions. This investigation is conducted at a Level II trauma center and is sponsored by Ascension Health. The study has two groups: one group receives 1 gram of TXA soon after diagnosis plus an additional gram during surgery, totaling 2 grams; the other group receives only the intraoperative dose of 2 grams. TXA is given intravenously, with one dose infused before incision and the other at wound closure. Participants are randomly assigned to one of these groups to compare outcomes. Participants will be monitored for up to two weeks after surgery to measure outcomes like overall blood loss, need for blood transfusions, length of hospital stay, postoperative pain, wound complications, and occurrence of acute deep vein thrombosis or pulmonary embolism. The study involves assessments during hospital stay and follow-up to track these measures and ensure participant safety.
CONDITIONS
Brief Title
Effect of Early Administration of TXA in Adult Hip Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult hip fracture patients aged 18 years or older
- Acute hip fracture diagnosis
- Undergoing operative fixation surgery
You will not qualify if you...
- Polytrauma patients
- Previous operation on the same (ipsilateral) hip
- Blood clotting disorders such as Factor V Leiden or Sickle Cell Anemia
- History of thromboembolic events, stroke, cardiac stents, or heart attack within the past 6 months
- History of seizure disorder
- Use of birth control
- Pregnant women
- Prisoners
- Active blood clotting disease such as DVT, PE, MI, or stroke
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 weeks
Participants receive Tranexamic Acid (TXA) either early after diagnosis and during surgery or only during surgery to reduce blood loss.
1 to 2 visits depending on timing of TXA administration (emergency department and/or intraoperative)
Trial Site Locations
Total: 1 location
1
Ascension Genesys Hospital
Grand Blanc, Michigan, United States, 48439
Actively Recruiting
Research Team
J
Jacob Hinkley, DO, MS
J
Jacob Lytle, DO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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