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

NCT05518279 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: 11411
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Fractures; Blood Loss

Keywords

hip fracture; blood loss; tranexamic acid

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• Estimated blood loss

  Starting at time of surgical incision and will end once the surgery is completed.

• Frequency of adverse events.

  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.

Study Arms (2)

Tranexamic Acid Treatment Group

ACTIVE COMPARATOR

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

Oral Placebo Control Group

PLACEBO COMPARATOR

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

Interventions

Tranexamic Acid Pill 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.

Tranexamic Acid Treatment Group

Placebo Oral Tablet 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.

Oral Placebo Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Henry Ford Health System: lead

MeSH Terms

Conditions

Hip Fractures; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Trent Guthrie, MD

  Henry Ford Hospital Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both participants and treatment team will be blinded to the treatment medication.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Orthopaedic Surgery, Trauma Division; Program Director: Orthopaedic Surgery Residency

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: August 26, 2022
• Study Start: September 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share