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

NCT ID: NCT05518279

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2021-09-30

Brief Summary

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.

Detailed 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.

Conditions

Hip Fractures; Blood Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tranexamic Acid Treatment Group

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.

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid Pill

Intervention Type: DRUG

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.

Oral Placebo Control Group

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.

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

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.

Interventions

Tranexamic Acid Pill

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.

Intervention Type: DRUG

Placebo Oral Tablet

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.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Trent Guthrie

Department of Orthopaedic Surgery, Trauma Division; Program Director: Orthopaedic Surgery Residency

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trent Guthrie, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Hospital Department of Orthopaedic Surgery

Other Identifiers

11411

Identifier Type: -

Identifier Source: org_study_id