Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures

Henry Ford Health

Status and phase: Withdrawn; Phase 3

Conditions: Hip Fractures; Blood Loss

Treatments: Drug: Tranexamic Acid Pill; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05518279

11411

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 50
• Clinical diagnosis of acute femoral neck, intertrochanteric or subtrochanteric femur fracture

Exclusion criteria

• anticoagulant use at time of admission to emergency department
• documented allergy to tranexamic acid
• history of deep vein thrombosis or pulmonary embolism
• hepatic dysfunction (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 60)
• renal dysfunction (Creatinine > 1.5 or Glomerular Filtration Rate < 30)
• active coronary artery disease (event within 12 months)
• history of cerebral vascular accident within 12 months
• presence of drug eluting stent
• color blindness
• active cancer
• coagulopathy (International Normalized Ratio > 1.4, Partial Thromboplastin Time > 1.4 times normal, platelets < 50,000)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Tranexamic Acid Treatment Group

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic Acid Pill

Oral Placebo Control Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Oral Tablet