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

Hip Fractures Clinical Trial

Official title:

Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures: A Prospective, Randomized, Double-blinded, Placebo Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05518279
• Other study ID #: 11411
• Status: Withdrawn
• Phase: Phase 3
• Start date: September 2019
• Est. completion date: September 2021

Study information

• Verified date: August 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Blood Loss
• Fractures, Bone
• Hemorrhage
• Hip Fractures

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	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.
Secondary	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.	Starting at time of surgical incision and will end once the surgery is completed.
Secondary	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.	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.