A Phase 3 interventional study of Tranexamic Acid Pill and Placebo Oral Tablet in Hip Fractures and Blood Loss, sponsored by Henry Ford Health System. Withdrawn. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-08-26.
Sponsored by Henry Ford Health System · Phase 3, Interventional, and Treatment
The study is a prospective, randomized, double blinded, placebo controlled trial that aims to investigate the hypothesis that early administration of tranexamic acid (TXA) following diagnosis of hip fracture will lower pre and postoperative blood loss and transfusion rates. Patients who present to the hospital with a hip fracture will be recruited and randomized into two treatment arms. The treatment group will receive 1950mg of oral TXA (three tablets, 650 mg each) and the control group will be given three tablets of oral placebo while in the Emergency Department. Patients will then be admitted to the Orthopaedic Trauma service and treated surgically with cephalomedullary nail, hemiarthroplasty, sliding hip screw, percutaneous screws, or total hip arthroplasty.
There remains a high incidence of blood transfusion in patients following hip fractures. Tranexamic acid (TXA) has well-studied efficacy in decreasing blood loss and transfusion requirements in the context of general trauma, as well as several elective orthopaedic procedures. Although blood is lost in hip fracture surgery itself, it is also known that there is significant blood loss pre-operatively following the hip fracture event, particularly in extracapsular hip fractures. A prospective, randomized, double blinded, placebo controlled trial will elucidate the roll of early administration of TXA in a population of patients who sustain hip fractures. The study aims to investigate the hypothesis that early administration of TXA following diagnosis of hip fracture will lower pre and postoperative blood loss and transfusion rates. There will be two treatment arms in the study. The treatment group will be given 1950mg of oral TXA (3 tablets, 650mg each) in the emergency department following diagnosis of hip fracture. Those randomized to the control group will be given 3 tablets of oral placebo in the emergency department following diagnosis of hip fracture. Patients will then be admitted to the Orthopaedic Trauma service and treated surgically with cephalomedullary nail, hemiarthroplasty, sliding hip screw, percutaneous screws, or total hip arthroplasty.
848 studies on the registry are indexed under Hip Fractures; 160 are open to participants now.
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Exclusion Criteria:
The intervention for the treatment group is as follows: participants in this treatment arm will given 1950mg of oral tranexamic acid pills (3 tablets, 650mg each) in the emergency department following diagnosis of hip fracture.
Drug: Tranexamic Acid Pill
The intervention for the control group is as follows: participants in this treatment arm will given 3 tablets of oral placebo pills in the emergency department following diagnosis of hip fracture.
Drug: Placebo Oral Tablet
Patients will receive 1950mg of an oral tranexamic acid pill (3 pills total) while down in the Emergency Department after being diagnosed with a hip fracture. After they receive the oral TXA and are medically optimized, they will be taken to the operating room for fracture fixation.
Patients in the control arm will receive 3 placebo pills while down in the Emergency Department after being diagnosed with a hip fracture. After they receive the placebo pills and are medically optimized for surgery, they will be taken to the operating room for fracture fixation.
Blood transfusion rate
Preoperative, intraoperative, and postoperative blood transfusions will be considered as the primary outcome measure. This outcome will be measured in number of units of packed red blood cells administered during the participant's hospital stay.
Time frame: This outcome will be recorded daily from the time of admission to the Emergency Department through the time of discharge from the hospital, assessed up to 7 days.
Hemoglobin Level
Labs, specifically a complete blood count (CBC) to evaluate a hemoglobin level (in grams per deciliter), will be drawn at the following time points: Admission to the Emergency Department, nightly (9pm) for each day of hospitalization and one hour after completion of a blood transfusion.
Time frame: This outcome will be recorded daily from the time of admission to the Emergency Department to the time of discharge from the hospital, up to 7 days.
Estimated blood loss
Measured amount of blood loss recorded during the surgery. These values will be compared between the two study arms to determine if administration of oral TXA decreases the intra-operative blood loss.
Time frame: Starting at time of surgical incision and will end once the surgery is completed.
Frequency of adverse events.
Documentation of any adverse events in the peri-operative period. For example, transfusion reaction, myocardial infarction, symptomatic deep vein thrombosis, pulmonary embolism, stroke, reoperation, readmission, infection, and death.
Time frame: From time of admission to the Emergency department up to 12 months after the date of surgery. Outcome measure will be recorded daily while participant is hospitalized and monthly after discharge from the hospital.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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