Effect of Early Administration of TXA in Adult Hip Fractures

NCT05047133 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 1722787-1
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Blood Loss

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Length of hospital stay

  Up to two weeks

• Postoperative Pain

  Up to two weeks

• Wound complications

  Up to two weeks

• Acute DVT/PE

  Up to two weeks

Study Arms (2)

Early Adminstration of TXA + Intraoperative TXA

EXPERIMENTAL

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

Intraoperative only TXA

OTHER

This group will only receive the intraoperative TXA.

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

TXA to be given at time of diagnosis in the emergency department (ED) in treatment group and at time of operation for both groups

Also known as: Lysteda

Early Adminstration of TXA + Intraoperative TXA; Intraoperative only TXA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ascension Health: lead

Study Sites (1)

Ascension Genesys Hospital

Grand Blanc, Michigan, 48439, United States

RECRUITING

MeSH Terms

Conditions

Postoperative Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Jacob Hinkley, DO, MS

CONTACT

810-606-5669; jacob.hinkley2@ascension.org

Jacob Lytle, DO

CONTACT

810-606-5669; jacob.lytle@ascension.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 16, 2021
• Study Start: September 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)