Effect of Early Administration of TXA in Adult Hip Fractures

Does Early Administration of Tranexamic Acid Decrease Perioperative Blood Loss in Addition to Intraoperative Tranexamic Acid for Hip Fracture Patients?

This is a prospective clinical study designed to assess blood loss in intracapsular and extracapsular hip fractures undergoing operative fixation at a Level II trauma center. It is well established in the orthopedic literature that tranexamic acid (TXA) decreases blood loss and need for postoperative blood transfusion in hip fracture patients as well as total joint arthroplasty patients. A typical dosing pattern, and the dosing pattern employed at our institution, is 1 gram IV infused prior to incision followed by 1 gram IV infused at the time of wound closure.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Blood Loss
• Intervention / Treatment: Drug: Tranexamic acid

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Jacob Hinkley, DO, MS; Phone Number: 810-606-5669; Email: jacob.hinkley2@ascension.org
• Study Contact Backup: Name: Jacob Lytle, DO; Phone Number: 810-606-5669; Email: jacob.lytle@ascension.org

Study Locations

• United States
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Recruiting
      • Ascension Genesys Hospital
      • Contact: Sandra Watt, MS, BSN; Phone Number: 810-606-7713; Email: sandra.watt@ascension.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. All adult (18 years old or older) hip fracture patients presenting with an acute hip fracture and undergoing operative fixation

Exclusion Criteria:

1. Polytrauma patients
2. Previous operation on the ipsilateral hip
3. Patients with coagulopathies (Factor V Leiden, Sickle Cell Anemia, Etc.)
4. Patients with < 6-month history of thromboembolic event (DVT/PE), Stroke, Cardiac Stents, or Myocardial Infarction (MI)
5. History of seizure disorder
6. Patients on birth control
7. Pregnant Women
8. Prisoners
9. Active thromboembolic disease (DVT/PE, MI, Stroke)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Adminstration of TXA + Intraoperative TXA; This group receives 1 G of TXA as soon as possible after a diagnosis of an acute hip fracture if the patient meets inclusion and exclusion criteria. The group will also receive 2 grams of TXA total intraoperatively.	Drug: Tranexamic acid; TXA to be given at time of diagnosis in the emergency department (ED) in treatment group and at time of operation for both groups; Other Names: Lysteda
Other: Intraoperative only TXA; This group will only receive the intraoperative TXA.	Drug: Tranexamic acid; TXA to be given at time of diagnosis in the emergency department (ED) in treatment group and at time of operation for both groups; Other Names: Lysteda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Blood Transfusion	Patient receives a blood transfusion during their postoperative stay in the hospital	Up to two weeks
Overall Blood Loss	Calculate the difference in postoperative blood loss between groups	Up to two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Overall length of hospital stay	Up to two weeks
Postoperative Pain	Difference in overall pain scores between groups	Up to two weeks
Wound complications	Acute wound complications documented after surgical intervention	Up to two weeks
Acute DVT/PE	Documented deep venous thrombosis or pulmonary embolism	Up to two weeks

Collaborators and Investigators

• Sponsor: Ascension Genesys Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hemorrhage; Hip Fractures; Postoperative Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 1722787-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes